The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Hyperflex Flexible Guidewires.
| Device ID | K941711 |
| 510k Number | K941711 |
| Device Name: | HYPERFLEX FLEXIBLE GUIDEWIRES |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-06 |
| Decision Date | 1994-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845854025331 | K941711 | 000 |
| 00845854025317 | K941711 | 000 |