The following data is part of a premarket notification filed by Map Medical Equipment, Inc. with the FDA for Map Multitrack Angiographic Catheter (4f).
| Device ID | K952984 |
| 510k Number | K952984 |
| Device Name: | MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MAP MEDICAL EQUIPMENT, INC. 10750 U.S. HIGHWAY II North Lawrence, NY 12967 |
| Contact | Michael L Martin |
| Correspondent | Michael L Martin MAP MEDICAL EQUIPMENT, INC. 10750 U.S. HIGHWAY II North Lawrence, NY 12967 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1996-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887714024525 | K952984 | 000 |
| 10887714024518 | K952984 | 000 |
| 04046964336089 | K952984 | 000 |
| 04046964312748 | K952984 | 000 |
| 04046964312724 | K952984 | 000 |
| 04046964312700 | K952984 | 000 |