The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Entre Ii Ptca Guide Wire.
| Device ID | K935577 |
| 510k Number | K935577 |
| Device Name: | SCIMED ENTRE II PTCA GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Contact | Deborah L Jensen |
| Correspondent | Deborah L Jensen SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-02-14 |