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FDA 510(k)

BETTER-BLADDER (BB)

K-Number: K964337 · 1997-05-23

ApplicantCirculatory Technology, Inc.
Decision Date1997-05-23
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BETTER-BLADDER (BB) is the device name listed in this FDA 510(k) record. The listed applicant is Circulatory Technology, Inc.. It received FDA 510(k) clearance on 1997-05-23 under 510(k) number K964337. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETTER-BLADDER (BB)?

BETTER-BLADDER (BB) is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K964337.

When did BETTER-BLADDER (BB) receive FDA 510(k) clearance?

BETTER-BLADDER (BB) received FDA 510(k) clearance on 1997-05-23, under 510(k) number K964337.

Who is the listed applicant for BETTER-BLADDER (BB)?

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

What is the FDA product code for BETTER-BLADDER (BB)?

The FDA product code for BETTER-BLADDER (BB) is FIB.

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Other records listing Circulatory Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012942THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500K001822THE V-BAGK981284BETTER-BLADDER (BB)K964205BETTER-TUBINGK961594BETTER-VENTERK941492PRESSURE RELIEF VALVE

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Related Devices (Code: FIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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