BARD STONE REMOVAL BALLOON CATHETER— 510(k) K920342
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K920342 for BARD STONE REMOVAL BALLOON CATHETER, Substantially Equivalent on 1992-08-26. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tewksbury, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.