The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Intra-aortic Balloon For Optional Sheathless Insertion.
| Device ID | K940231 |
| 510k Number | K940231 |
| Device Name: | INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | John Picciano |
| Correspondent | John Picciano DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-18 |
| Decision Date | 1994-09-13 |