The following data is part of a premarket notification filed by Disco, Inc. with the FDA for Femoral Artery Pressure Pad/disk.
| Device ID | K914149 |
| 510k Number | K914149 |
| Device Name: | FEMORAL ARTERY PRESSURE PAD/DISK |
| Classification | Clamp, Vascular |
| Applicant | DISCO, INC. 6611 S.W. BURLINGAME AVE. Portland, OR 97201 |
| Contact | Byron Zahler |
| Correspondent | Byron Zahler DISCO, INC. 6611 S.W. BURLINGAME AVE. Portland, OR 97201 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-16 |
| Decision Date | 1991-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811331013252 | K914149 | 000 |
| 00811331010480 | K914149 | 000 |
| 00811331011838 | K914149 | 000 |
| 00811331011715 | K914149 | 000 |
| 00811331013245 | K914149 | 000 |