K002033 is an FDA 510(k) clearance for the BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on July 26, 2000, 21 days after receiving the submission on July 5, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K002033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2000 |
| Decision Date | July 26, 2000 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |