The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Viper Percutaneous Transluminal Angioplasty (pta) Catheter.
| Device ID | K944815 |
| 510k Number | K944815 |
| Device Name: | SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1994-11-14 |