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FDA 510(k)

primeMidline Catheters

K-Number: K192802 · 2019-10-28

ApplicantPfm Medical, Inc.
Decision Date2019-10-28
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

primeMidline Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2019-10-28 under 510(k) number K192802. 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 primeMidline Catheters?

primeMidline Catheters is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K192802.

When did primeMidline Catheters receive FDA 510(k) clearance?

primeMidline Catheters received FDA 510(k) clearance on 2019-10-28, under 510(k) number K192802.

Who is the listed applicant for primeMidline Catheters?

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

What is the FDA product code for primeMidline Catheters?

The FDA product code for primeMidline Catheters is PND.

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Related Devices (Code: PND)

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.

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLCK181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USAK173114primeMidline CathetersPfm Medical, Inc.

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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