The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Iab Anchor.
| Device ID | K922103 |
| 510k Number | K922103 |
| Device Name: | IAB ANCHOR |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Larry Korona |
| Correspondent | Larry Korona DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1993-08-03 |