The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Opti-plast (centurion) 5.5f Angioplasty Catheter.
| Device ID | K973013 |
| 510k Number | K973013 |
| Device Name: | OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | VAS-CATH, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Donna J Wilson |
| Correspondent | Donna J Wilson VAS-CATH, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1998-06-19 |
| Summary: | summary |