Submission Details
| 510(k) Number | K071095 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2007 |
| Decision Date | May 18, 2007 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
ASPIRA PLEURAL DRAINAGE SYSTEM
May 2007
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K071095 is an FDA 510(k) clearance for the ASPIRA PLEURAL DRAINAGE SYSTEM, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 18, 2007, 30 days after receiving the submission on April 18, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.
Device Classification
| Product Code | DWM — Apparatus, Suction, Patient Care |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5050 |
Manufacturer
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