The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ultraverse 014 And 018 Pta Balloon Dilatation Catheters Line Extension.
| Device ID | K121856 |
| 510k Number | K121856 |
| Device Name: | ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Contact | Erin Fox |
| Correspondent | Erin Fox C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2012-07-11 |
| Summary: | summary |