The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Workhorse Percutaneous Transluminal Angioplasty Balloon Catheter.
| Device ID | K991540 |
| 510k Number | K991540 |
| Device Name: | WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-09-29 |