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FDA 510(k)

BT-CATH

K-Number: K101535 · 2011-01-11

ApplicantUtah Medical Products, Inc.
Decision Date2011-01-11
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BT-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 2011-01-11 under 510(k) number K101535. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BT-CATH?

BT-CATH is a medical device that received FDA 510(k) clearance on 2011-01-11. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K101535.

When did BT-CATH receive FDA 510(k) clearance?

BT-CATH received FDA 510(k) clearance on 2011-01-11, under 510(k) number K101535.

Who is the listed applicant for BT-CATH?

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

What is the FDA product code for BT-CATH?

The FDA product code for BT-CATH is OQY.

Other records listing Utah Medical Products, Inc. as applicant

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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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