Submission Details
| 510(k) Number | K191232 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2019 |
| Decision Date | September 18, 2019 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
AccuCath Ace Intravascular Catheter
Sep 2019
Decision
133d
Days
Class 2
Risk
About This 510(k) Submission
K191232 is an FDA 510(k) clearance for the AccuCath Ace Intravascular Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 18, 2019, 133 days after receiving the submission on May 8, 2019. 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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