510(k) K803037
K803037 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "WILLIAM HARVEY VENTED MEDIASTINAL DRAIN". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1981
- Date Received
- December 1, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Patient Care
- Device Class
- Class II
- Regulation Number
- 870.5050
- Review Panel
- AN
- Submission Type