FDA Product Code
FDA Product Code MSD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 124 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022000 | POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) | Spire Biomedical, Inc. | 2002-07-19 | Special | PDF ↗ |
| K020315 | 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL | Medcomp | 2002-05-24 | Traditional | PDF ↗ |
| K020465 | MEDCOMP ASH SPLIT-CATH II | Medcomp | 2002-05-22 | Traditional | PDF ↗ |
| K021212 | 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | Spire Biomedical, Inc. | 2002-05-17 | Special | PDF ↗ |
| K013160 | POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER | Spire Biomedical, Inc. | 2002-04-11 | Traditional | PDF ↗ |
| K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | Medical Components, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K011916 | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES | Horizon Medical Products, Inc. | 2001-10-31 | Traditional | PDF ↗ |
| K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Medical Components, Inc. | 2001-10-03 | Traditional | PDF ↗ |
| K012948 | MODIFICATION TO VAXCEL DIALYSIS CATHETER | Boston Scientific/Medi-Tech | 2001-10-03 | Special | PDF ↗ |
| K010306 | MEDCOMP EXCELL SPLIT TIP CATHETER | Medcomp | 2001-10-03 | Traditional | PDF ↗ |
| K012365 | VAXCEL DIALYSIS CATHETER | Boston Scientific Corp | 2001-08-24 | Special | PDF ↗ |
| K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | Diatek, Inc. | 2001-08-14 | Traditional | PDF ↗ |
| K003207 | MEDCOMP ULTRA-FLOW CATHETER | Medical Components, Inc. | 2001-06-12 | Traditional | PDF ↗ |
| K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | The Kendall Company | 2001-04-09 | Traditional | PDF ↗ |
| K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER | The Kendall Company | 2001-03-28 | Traditional | PDF ↗ |
| K010567 | OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR | C.R. Bard, Inc. | 2001-03-28 | Special | PDF ↗ |
| K001633 | LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 | Vasca, Inc. | 2000-08-24 | Traditional | PDF ↗ |
| K982326 | MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY | Boston Scientific Corp | 1999-07-12 | Traditional | PDF ↗ |
| K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | Medical Components, Inc. | 1999-02-26 | Traditional | PDF ↗ |
| K982333 | MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY | Cook, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Sherwood Medical Co. | 1998-11-25 | Traditional | PDF ↗ |
| K981994 | VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER | C.R. Bard, Inc. | 1998-09-03 | Traditional | PDF ↗ |
| K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) | Medical Components, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K972207 | MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM | Medcomp | 1998-02-23 | Traditional | PDF ↗ |
Product code MSD · Class II · Gastroenterology, Urology. Data: openFDA.