The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Optamum Operative Peripheral Angioplas Cath.
| Device ID | K911870 |
| 510k Number | K911870 |
| Device Name: | SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Contact | David A Teicher |
| Correspondent | David A Teicher SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-26 |
| Decision Date | 1991-08-12 |