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Davol Implant Ports W/Attach Hi Perf Groshong Cath

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913235

by Davol Inc.

Identifiers

510(k) Number
K913235 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Davol Implant Ports W/Attach Hi Perf Groshong Cath by Davol Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Davol Inc.
FDA Applicant
Davol, Inc.

Sources (1)

  • FDA 510(k) K913235 24 fields · synced Jun 19, 2026