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FDA 510(k)

PROCEDURE PACKS CONTRAST MEDIA SETS

K-Number: K882717 · 1988-12-28

ApplicantProcedure Packs, Inc.
Decision Date1988-12-28
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROCEDURE PACKS CONTRAST MEDIA SETS is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Packs, Inc.. It received FDA 510(k) clearance on 1988-12-28 under 510(k) number K882717. 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 PROCEDURE PACKS CONTRAST MEDIA SETS?

PROCEDURE PACKS CONTRAST MEDIA SETS is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is Procedure Packs, Inc.. The 510(k) number is K882717.

When did PROCEDURE PACKS CONTRAST MEDIA SETS receive FDA 510(k) clearance?

PROCEDURE PACKS CONTRAST MEDIA SETS received FDA 510(k) clearance on 1988-12-28, under 510(k) number K882717.

Who is the listed applicant for PROCEDURE PACKS CONTRAST MEDIA SETS?

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

What is the FDA product code for PROCEDURE PACKS CONTRAST MEDIA SETS?

The FDA product code for PROCEDURE PACKS CONTRAST MEDIA SETS is DTL.

Related Clinical Trials

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.

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Other records listing Procedure Packs, Inc. as applicant

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.

K891572ANGIOGRAPHY CUSTOM PACKSK882716PROCEDURE PACKS SOLUTION ADMINISTRATION SETSK882655PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE

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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