The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Balloon Dilatation Catheter.
| Device ID | K894944 |
| 510k Number | K894944 |
| Device Name: | BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Laurie Ayres |
| Correspondent | Laurie Ayres PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1990-01-19 |