The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Mega 8fr. 50cc And Sensation Plus 8fr. 50cc Intra-aortic Balloon Catheters And Accessories.
| Device ID | K133074 |
| 510k Number | K133074 |
| Device Name: | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Linda Slutzky |
| Correspondent | Linda Slutzky DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2013-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567108599 | K133074 | 000 |
| 10607567107493 | K133074 | 000 |
| 10607567113272 | K133074 | 000 |
| 10607567113265 | K133074 | 000 |
| 10607567113173 | K133074 | 000 |