The following data is part of a premarket notification filed by Datascope Corp., Cardiac Assist Division with the FDA for Air-band Radial Compression Device.
| Device ID | K122405 |
| 510k Number | K122405 |
| Device Name: | AIR-BAND RADIAL COMPRESSION DEVICE |
| Classification | Clamp, Vascular |
| Applicant | DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Contact | Carla S Cerqueira |
| Correspondent | Carla S Cerqueira DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. Fairfield, NJ 07004 -0011 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-07 |
| Decision Date | 2012-11-09 |
| Summary: | summary |