FDA Product Code
FDA Product Code DRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5225
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | 2025-12-22 | Traditional | PDF ↗ |
| K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. | 2020-08-28 | Special | PDF ↗ |
| K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | Omay(Guangzhou)Med Technologies Co., Ltd. | 2020-08-05 | Traditional | PDF ↗ |
| K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019-09-10 | Traditional | PDF ↗ |
| K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018-05-30 | Traditional | PDF ↗ |
| K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015-12-17 | Traditional | PDF ↗ |
| K130439 | EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING | Chongqing Psk Sci-Tech Development Co., Ltd. | 2013-12-12 | Traditional | PDF ↗ |
| K082134 | CIRCULATOR BOOT | Circulator Boot Corp. | 2009-05-07 | Traditional | PDF ↗ |
| K081359 | GENESIS ECP | Scottcare Corporation | 2008-05-29 | Special | PDF ↗ |
| K052611 | ECP HEALTH SYSTEM, MODEL 2005 | Ecp Health, Inc. | 2006-04-26 | Traditional | PDF ↗ |
| K050172 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 | Cardiomedics, Inc. | 2005-03-31 | Traditional | PDF ↗ |
| K042413 | ACS MODEL NCP-2 | Applied Cardiac Systems | 2004-12-09 | Traditional | PDF ↗ |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | Vasomedical, Inc. | 2004-03-01 | Traditional | PDF ↗ |
| K033657 | MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V | Living Data Technologies Corporation | 2003-12-19 | Special | PDF ↗ |
| K030587 | EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP | S-Tct Health, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K030532 | CPCA2000 COUNTERPULSATION SYSTEM | Cpca2000, Inc. | 2003-03-14 | Traditional | PDF ↗ |
| K023701 | ANGIONEW-IV | Living Data Technologies Corporation | 2003-01-30 | Traditional | PDF ↗ |
| K021340 | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE | External Counterpulsation Lab | 2003-01-30 | Traditional | PDF ↗ |
| K022078 | SOLA, COUNTER-PULSATION, MODEL SECP-S | Sola Medical Devices, LLC | 2003-01-10 | Traditional | PDF ↗ |
| K023427 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2003-01-07 | Traditional | PDF ↗ |
| K023016 | NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE | Nicore Equipment & Leasing, Inc. | 2002-12-04 | Traditional | PDF ↗ |
| K022107 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2002-08-08 | Traditional | PDF ↗ |
| K020857 | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER | Vasomedical, Inc. | 2002-06-14 | Traditional | PDF ↗ |
| K012141 | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE | External Counterpulsation Lab | 2001-10-25 | Traditional | PDF ↗ |
| K010261 | CARDIOMEDICS ECP SYSTEM | Cardiomedics, Inc. | 2001-02-28 | Special | PDF ↗ |
| K003469 | EECP THERAPY SYSTEM, MODEL TS3 | Vasomedical, Inc. | 2000-12-06 | Special | PDF ↗ |
| K980937 | NICORE MODEL ESP -1 | Nicore Equipment & Leasing, Inc. | 2000-09-15 | Traditional | PDF ↗ |
| K971026 | THE CIRCULATOR BOOT | Circulator Boot Corp. | 1997-08-14 | Traditional | PDF ↗ |
| K940264 | VASOGENICS EECP-MC2 | Vasogenics, Inc. | 1995-02-23 | Traditional | PDF ↗ |
| K882401 | STONY BROOK MODEL EECP-MC1 | Stony Brook Trading and Development Corp. | 1989-03-03 | Traditional | PDF ↗ |
| K872034 | CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM | Cardiomedics, Inc. | 1987-09-18 | Traditional | PDF ↗ |
| K833627 | CIRCULATOR MINIBOOT | Circulator Boot Corp. | 1984-05-23 | Traditional | PDF ↗ |
| K792430 | CARDIASSIST EXTERNAL COUNTERPULSATION | Cardiassist Corp. | 1980-01-23 | Traditional | PDF ↗ |
| K792354 | THE CIRCULATOR BOOT | Circulator Boot Corp. | 1980-01-09 | Traditional | PDF ↗ |
Product code DRN · Class II · Cardiovascular. Data: openFDA.