FDA 510(k)

Provena(TM) Midline Catheter

K-Number: K213203 · 2022-05-13

Decision Date2022-05-13

Product CodePND

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Provena(TM) Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K213203. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provena(TM) Midline Catheter?

Provena(TM) Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K213203.

When did Provena(TM) Midline Catheter receive FDA 510(k) clearance?

Provena(TM) Midline Catheter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213203.

Who is the listed applicant for Provena(TM) Midline Catheter?

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

What is the FDA product code for Provena(TM) Midline Catheter?

The FDA product code for Provena(TM) Midline Catheter is PND.

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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.