FDA 510(k)

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

K-번호: K160451 · 2016-06-20

신청자Kci USA, Inc. (Kinetic Concepts, Inc.)

결정일2016-06-20

제품 코드OMP

자문 위원회SU

결정Substantially Equivalent

기기 요약

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K160451. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K160451.

When did V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... receive FDA 510(k) clearance?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160451.

Who is the listed applicant for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

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

What is the FDA product code for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

The FDA product code for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is OMP.

Kci USA, Inc. (Kinetic Concepts, Inc.)를 신청인으로 등재한 기타 기록

K162790V.A.C.ULTA Negative Pressure Wound Therapy System K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

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