FDA 510(k)

TightRail Guardian Motorized Dilator Sheath

Número K: K212784 · 2022-08-24

Data da decisão2022-08-24

Código do produtoDRE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

TightRail Guardian Motorized Dilator Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K212784. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TightRail Guardian Motorized Dilator Sheath?

TightRail Guardian Motorized Dilator Sheath is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Spectranetics, Inc.. The 510(k) number is K212784.

When did TightRail Guardian Motorized Dilator Sheath receive FDA 510(k) clearance?

TightRail Guardian Motorized Dilator Sheath received FDA 510(k) clearance on 2022-08-24, under 510(k) number K212784.

Who is the listed applicant for TightRail Guardian Motorized Dilator Sheath?

The FDA 510(k) record lists Spectranetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TightRail Guardian Motorized Dilator Sheath?

The FDA product code for TightRail Guardian Motorized Dilator Sheath is DRE.

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Outros registros que listam Spectranetics, Inc. como candidato(a)

K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K203540Bridge Occlusion Balloon K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K170059Spectranetics Turbo-Elite Laser Atherectomy Catheters

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: DRE)

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

Fonte oficial

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