The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed(r) Entre(tm) Ii Ptca Guide Wire & Accessory.
| Device ID | K931514 |
| 510k Number | K931514 |
| Device Name: | SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-26 |
| Decision Date | 1993-06-25 |