The following data is part of a premarket notification filed by Bolton Medical, Inc. with the FDA for Bolton Pta Catheter.
| Device ID | K021996 |
| 510k Number | K021996 |
| Device Name: | BOLTON PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Bolton Medical, Inc. 16-00 POLLITT DR. Fair Lawn, NJ 07410 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly Bolton Medical, Inc. 16-00 POLLITT DR. Fair Lawn, NJ 07410 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-08-23 |
| Summary: | summary |