FDA Product Code
FDA Product Code DRC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1390
510(k) Clearances — 51 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | 2024-07-26 | Traditional | PDF ↗ |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | 2024-05-17 | Special | PDF ↗ |
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | 2022-09-14 | Special | PDF ↗ |
| K212625 | PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | 2022-03-23 | Traditional | PDF ↗ |
| K210328 | SafeSept Blunt Needle | Pressure Products Medical Device Manufacturing, LLC | 2021-03-05 | Special | PDF ↗ |
| K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | 2018-02-21 | Traditional | PDF ↗ |
| K172934 | Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC | 2018-02-16 | Traditional | PDF ↗ |
| K172893 | SafeSept Needle Free Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | 2017-12-21 | Traditional | PDF ↗ |
| K170671 | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | 2017-10-20 | Traditional | PDF ↗ |
| K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | Synaptic Medical Limited | 2014-08-29 | Traditional | PDF ↗ |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | 2014-01-08 | Traditional | PDF ↗ |
| K122587 | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013-02-07 | Special | PDF ↗ |
| K122832 | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | 2012-12-19 | Special | PDF ↗ |
| K111644 | MOBICATH TRANSSEPTAL NEEDLE | Great Batch Medical | 2011-10-03 | Traditional | PDF ↗ |
| K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | Oscor, Inc. | 2008-11-14 | Traditional | PDF ↗ |
| K072278 | BRK TRANSSEPTAL NEEDLE | St Jude Medical | 2007-09-13 | Traditional | PDF ↗ |
| K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | Hansen Medical, Inc. | 2006-10-13 | Traditional | PDF ↗ |
| K022117 | MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 | Merit Medical Systems, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K022257 | VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX | Vomed Volzer Medizintechnik GmbH & Co. | 2002-10-04 | Traditional | PDF ↗ |
| K011727 | TRANSSEPTAL NEEDLE/TROCAR | Thomas Medical Products, Inc. | 2002-05-02 | Traditional | PDF ↗ |
| K011373 | INSTRUMENT DAMPING PORT | Medcanica, Inc. | 2001-10-12 | Traditional | PDF ↗ |
| K011349 | INTERCOSTAL LOCKABLE-DIRECTABLE PORT | Medcanica, Inc. | 2001-10-05 | Traditional | PDF ↗ |
| K974745 | MANAN GWI GUIDE WIRE INTRODUCER | Medical Device Technologies, Inc. | 1998-04-06 | Traditional | PDF ↗ |
| K974743 | MANAN | Medical Device Technologies, Inc. | 1998-04-06 | Traditional | PDF ↗ |
| K974742 | MANAN POTTS-COURNAND NEEDLE | Medical Device Technologies, Inc. | 1998-04-06 | Traditional | PDF ↗ |
| K964302 | HEARTPORT THORACIC TROCAR | Heartport, Inc. | 1997-05-09 | Traditional | PDF ↗ |
| K965051 | HEARTPORT NEEDLE TROCAR | Heartport, Inc. | 1997-03-12 | Traditional | PDF ↗ |
| K951448 | GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE | Global Medical Products, Ltd. | 1996-03-27 | Traditional | PDF ↗ |
| K936247 | MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Medicon Instruments, Inc. | 1994-05-19 | Traditional | PDF ↗ |
| K940036 | ENDOSURG DISPOSABLE SECONDARY TROCAR | Endosurg | 1994-05-12 | Traditional | PDF ↗ |
| K924338 | ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE | Arrow Intl., Inc. | 1993-03-18 | Traditional | PDF ↗ |
| K913267 | R-GROUP INTL. ONE WALL PUNCTURE NEEDLE | R-Group Intl. | 1992-06-05 | Traditional | PDF ↗ |
| K914985 | DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION | E-Z-Em, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K911483 | LAPAROSCOPIC TROCAR | United States Endoscopy Group, Inc. | 1991-07-02 | Traditional | PDF ↗ |
| K911462 | SURGICAL TROCAR | Applied Medical | 1991-04-22 | Traditional | PDF ↗ |
| K900664 | DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES | Sterimed, Inc. | 1990-07-18 | Traditional | PDF ↗ |
| K895455 | SELDINGER PERCUTANEOUS 2 PC NEEDLES | Advance Medical Designs, Inc. | 1989-11-14 | Traditional | PDF ↗ |
| K895454 | SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) | Advance Medical Designs, Inc. | 1989-11-14 | Traditional | PDF ↗ |
| K893707 | AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT | United States Surgical, A Division of Tyco Healthc | 1989-06-15 | Traditional | PDF ↗ |
| K890209 | DISPOSABLE ANGIOGRAPHY NEEDLES | E-Z-Em, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K871377 | NAMIC COURNAND STYLE INTRODUCER NEEDLE | North American Instrument Corp. | 1987-05-07 | Traditional | PDF ↗ |
| K871378 | NAMIC SELDINGER INTRODUCER NEEDLE | North American Instrument Corp. | 1987-05-06 | Traditional | PDF ↗ |
| K871382 | NAMIC ONE PART INTRODUCER NEEDLE | North American Instrument Corp. | 1987-05-06 | Traditional | PDF ↗ |
| K854293 | MEDSURG POTT-COURNAND NEEDLE | Medsurg Industries, Inc. | 1986-01-15 | Traditional | PDF ↗ |
| K854294 | MEDSURG SELDINGER NEEDLE | Medsurg Industries, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K853132 | EMERSON TRO/CATH TROCAR CATHETERS | J. H. Emerson Co. | 1986-01-08 | Traditional | PDF ↗ |
| K840529 | STEIGER TUNNELING INSTRUMENT 285 | Evermed, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K811964 | VISITEC NEEDLE RANGE (CARDIOVASCULAR) | Visitec Co. | 1981-07-20 | Traditional | PDF ↗ |
| K781221 | DILUTION KIT, THERMAL, COLD PAC | Instrumentation Laboratory CO | 1978-08-23 | Traditional | PDF ↗ |
| K772369 | NEEDLES USED IN ANGIOGRAPHIC PROCED. | Argon Medical Corp. | 1978-01-24 | Traditional | PDF ↗ |
| K771261 | ADVANSET | C.R. Bard, Inc. | 1977-08-16 | Traditional | PDF ↗ |
Product code DRC · Class II · Cardiovascular. Data: openFDA.