K922103 is an FDA 510(k) clearance for the IAB ANCHOR. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on August 3, 1993, 454 days after receiving the submission on May 6, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K922103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1992 |
| Decision Date | August 03, 1993 |
| Days to Decision | 454 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KMK - Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |