FDA 510(k)

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

K-번호: K180738 · 2018-06-14

결정일2018-06-14

제품 코드EZD

자문 위원회GU

결정Substantially Equivalent

기기 요약

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Compactcath, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180738. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter?

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Compactcath, Inc.. The 510(k) number is K180738.

When did COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter receive FDA 510(k) clearance?

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180738.

Who is the listed applicant for COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter?

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

What is the FDA product code for COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter?

The FDA product code for COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter is EZD.

Compactcath, Inc.를 신청인으로 등재한 기타 기록

K160858CompactCath Intermittent Urinary Catheter

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