The following data is part of a premarket notification filed by Vascucare, Inc. with the FDA for Vascucare Percutaneous Angioscopy Delivery System.
| Device ID | K890047 |
| 510k Number | K890047 |
| Device Name: | VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM |
| Classification | Angioscope |
| Applicant | VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Contact | E Lipson |
| Correspondent | E Lipson VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-05 |
| Decision Date | 1989-06-20 |