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 a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2019-10-28 under approval 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. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K192802.
When was primeMidline Catheters approved by the FDA?
primeMidline Catheters received FDA 510(k) clearance on 2019-10-28, under approval number K192802.
What company makes primeMidline Catheters?
primeMidline Catheters is manufactured by Pfm Medical, Inc..
What is the FDA product code for primeMidline Catheters?
The FDA product code for primeMidline Catheters is PND.
Other Devices by Pfm Medical, Inc.
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K153393PowerMidline CatheterC.R. Bard, Inc.
K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)
K170770CT MidlineMedical Components, Inc. (dba MedComp)
K170158PowerGlide ST Midline CatheterC.R. Bard, 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.