Submission Details
| 510(k) Number | K971990 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 1997 |
| Decision Date | November 07, 1997 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
GESCO PER-Q-CATH PICC CATHETERS
Nov 1997
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K971990 is an FDA 510(k) clearance for the GESCO PER-Q-CATH PICC CATHETERS, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 7, 1997, 182 days after receiving the submission on May 9, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
Manufacturer
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