The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Turbo Support Catheter.
| Device ID | K910116 |
| 510k Number | K910116 |
| Device Name: | TURBO SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Paul Schneider |
| Correspondent | Paul Schneider DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-10 |
| Decision Date | 1991-06-25 |