K882383 is an FDA 510(k) clearance for the MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES. This device is classified as a Device, Biopsy, Endomyocardial (Class II - Special Controls, product code DWZ).
Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on November 28, 1988, 172 days after receiving the submission on June 9, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K882383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1988 |
| Decision Date | November 28, 1988 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWZ — Device, Biopsy, Endomyocardial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4075 |