The following data is part of a premarket notification filed by Pie Medical Equipment B.v. with the FDA for Caas Ii Lva Biplane Option.
| Device ID | K982203 |
| 510k Number | K982203 |
| Device Name: | CAAS II LVA BIPLANE OPTION |
| Classification | System, X-ray, Angiographic |
| Applicant | PIE MEDICAL EQUIPMENT B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
| Contact | Frank Aniba |
| Correspondent | Frank Aniba PIE MEDICAL EQUIPMENT B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-07-14 |
| Summary: | summary |