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FDA 510(k)

BETTER-BLADDER (BB)

K-Number: K981284 · 1998-08-12

ApplicantCirculatory Technology, Inc.
Decision Date1998-08-12
Product CodeDTN
Advisory CommitteeCV
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 1998-08-12 under 510(k) number K981284. The device is classified under product code DTN. It was reviewed by the CV 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 1998-08-12. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K981284.

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

BETTER-BLADDER (BB) received FDA 510(k) clearance on 1998-08-12, under 510(k) number K981284.

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 DTN.

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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-BAGK964205BETTER-TUBINGK964337BETTER-BLADDER (BB)K961594BETTER-VENTERK941492PRESSURE RELIEF VALVE

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Related Devices (Code: DTN)

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.

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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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