The following data is part of a premarket notification filed by Concert Medical, Llc with the FDA for S-wire Guidewire System.
| Device ID | K153397 |
| 510k Number | K153397 |
| Device Name: | S-Wire Guidewire System |
| Classification | Wire, Guide, Catheter |
| Applicant | CONCERT MEDICAL, LLC 77 ACCORD PARK DR. Norwell, MA 02061 |
| Contact | Timothy S. Powers |
| Correspondent | Pamela Papineau DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer, MA 01432 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814384020437 | K153397 | 000 |