The following data is part of a premarket notification filed by Stage 2 Innovations with the FDA for Renew Ncp-5 External Counterpulsation System.
| Device ID | K152115 |
| 510k Number | K152115 |
| Device Name: | Renew NCP-5 External Counterpulsation System |
| Classification | Device, Counter-pulsating, External |
| Applicant | Stage 2 Innovations 7811 Montrose Rd Rockville, MD 20854 |
| Contact | Richard Kotz |
| Correspondent | Janice M. Hogan HOGAN LOVELLS US, LLP 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-29 |
| Decision Date | 2015-12-17 |
| Summary: | summary |