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FDA 510(k)

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

K-Number: K945461 · 1995-02-03

ApplicantMedtronics Interventional Vascular
Decision Date1995-02-03
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronics Interventional Vascular. It received FDA 510(k) clearance on 1995-02-03 under 510(k) number K945461. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)?

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Medtronics Interventional Vascular. The 510(k) number is K945461.

When did PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) receive FDA 510(k) clearance?

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) received FDA 510(k) clearance on 1995-02-03, under 510(k) number K945461.

Who is the listed applicant for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)?

The FDA 510(k) record lists Medtronics Interventional Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)?

The FDA product code for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) is DTL.

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Other records listing Medtronics Interventional Vascular as applicant

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Related Devices (Code: DTL)

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

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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