DRN — Device, Counter-Pulsating, External Class II
FDA product code DRN covers "Device, Counter-Pulsating, External", a Class II medical device regulated under 21 CFR 870.5225. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRN
- Device Class
- Class II
- Regulation Number
- 870.5225
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250756 | pression | Pression Wave PRO External Counter-Pulsation System | December 22, 2025 |
| K202108 | vamed medical instrument co | External Counterpulsation System, Soulaire | August 28, 2020 |
| K191955 | omay(guangzhou)med technologies co | Enhanced External Counter Pulsation Device Plus Omay-A | August 5, 2020 |
| K190683 | vamed medical instrument co | External Counterpulsation System | September 10, 2019 |
| K173483 | xtreem pulse | Pure Flow External Counter-Pulsation Device | May 30, 2018 |
| K152115 | stage 2 innovations | Renew NCP-5 External Counterpulsation System | December 17, 2015 |
| K130439 | chongqing psk sci-tech development co | EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING | December 12, 2013 |
| K082134 | circulator boot | CIRCULATOR BOOT | May 7, 2009 |
| K081359 | scottcare corporation | GENESIS ECP | May 29, 2008 |
| K052611 | ecp health | ECP HEALTH SYSTEM, MODEL 2005 | April 26, 2006 |
| K050172 | cardiomedics | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 | March 31, 2005 |
| K042413 | applied cardiac systems | ACS MODEL NCP-2 | December 9, 2004 |
| K033617 | vasomedical | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | March 1, 2004 |
| K033657 | living data technologies corporation | MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V | December 19, 2003 |
| K030587 | s-tct health | EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP | May 30, 2003 |
| K030532 | cpca2000 | CPCA2000 COUNTERPULSATION SYSTEM | March 14, 2003 |
| K021340 | external counterpulsation lab | AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE | January 30, 2003 |
| K023701 | living data technologies corporation | ANGIONEW-IV | January 30, 2003 |
| K022078 | sola medical devices | SOLA, COUNTER-PULSATION, MODEL SECP-S | January 10, 2003 |
| K023427 | cardiomedics | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | January 7, 2003 |