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FDA 510(k)

CUSTOM CORONARY MANIFOLD KITS

K-Number: K853749 · 1986-01-13

ApplicantProcedure Products, Inc.
Decision Date1986-01-13
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CUSTOM CORONARY MANIFOLD KITS is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Products, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K853749. 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 CUSTOM CORONARY MANIFOLD KITS?

CUSTOM CORONARY MANIFOLD KITS is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Procedure Products, Inc.. The 510(k) number is K853749.

When did CUSTOM CORONARY MANIFOLD KITS receive FDA 510(k) clearance?

CUSTOM CORONARY MANIFOLD KITS received FDA 510(k) clearance on 1986-01-13, under 510(k) number K853749.

Who is the listed applicant for CUSTOM CORONARY MANIFOLD KITS?

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

What is the FDA product code for CUSTOM CORONARY MANIFOLD KITS?

The FDA product code for CUSTOM CORONARY MANIFOLD KITS 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 Products, Inc. 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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