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FDA 510(k)

ANGIOGRAPHY CUSTOM PACKS

K-Number: K891572 · 1989-07-24

ApplicantProcedure Packs, Inc.
Decision Date1989-07-24
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOGRAPHY CUSTOM PACKS 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 1989-07-24 under 510(k) number K891572. 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 ANGIOGRAPHY CUSTOM PACKS?

ANGIOGRAPHY CUSTOM PACKS is a medical device that received FDA 510(k) clearance on 1989-07-24. The listed applicant is Procedure Packs, Inc.. The 510(k) number is K891572.

When did ANGIOGRAPHY CUSTOM PACKS receive FDA 510(k) clearance?

ANGIOGRAPHY CUSTOM PACKS received FDA 510(k) clearance on 1989-07-24, under 510(k) number K891572.

Who is the listed applicant for ANGIOGRAPHY CUSTOM PACKS?

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 ANGIOGRAPHY CUSTOM PACKS?

The FDA product code for ANGIOGRAPHY CUSTOM PACKS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K882717PROCEDURE PACKS CONTRAST MEDIA SETSK882716PROCEDURE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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