Atlas FDA

DAVOL ARTHRO-FLO 3

FDA 510(k) clearance K951026 · decided 1995-06-02

Clearance details

K-number
K951026
Device name
DAVOL ARTHRO-FLO 3
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1995-03-06
Decision date
1995-06-02
Days to decision
88 days
Clearance type
Traditional
Product code
HRX
Device class
2
Regulation number
888.1100
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Cranston, RI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Avitene Flowable Collagen Hemostat (N17600/S043)Davol Inc., Sub. C. R. Bard, Inc.2025-06-10
Avitene™ Microfibrillar Collagen Hemostat (N17600/S044)Davol Inc., Sub. C. R. Bard, Inc.2025-05-20
Avitene Microfibrillar Collagen Hemostat (N17600/S042)Davol Inc., Sub. C. R. Bard, Inc.2025-03-13
AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) (N17600/S041)Davol Inc., Sub. C. R. Bard, Inc.2025-02-18
Avitene Flowable Collagen Hemostat (N17600/S040)Davol Inc., Sub. C. R. Bard, Inc.2024-12-18
Avitene™ Microfibrillar Collagen Hemostat (MCH) (N17600/S039)Davol Inc., Sub. C. R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (N17600/S037)Davol Inc., Sub. C. R. Bard, Inc.2023-10-04
Avitene™ Microfibrillar Collagen Hemostat (N17600/S038)Davol Inc., Sub. C. R. Bard, Inc.2023-04-25