The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope's 8fr. Alt B Iab; Datascope's Profile 8fr. Alt B Iab; Datascope's True Sheathless Dl 9.5 Fr. Iab; Datascope's.
| Device ID | K020257 |
| 510k Number | K020257 |
| Device Name: | DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Wolf |
| Correspondent | Joann Wolf DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-04-24 |
| Summary: | summary |