Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CUSTOM TUBING PACKS

K-Number: K913363 · 1991-12-20

ApplicantKroy Medical, Inc.
Decision Date1991-12-20
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CUSTOM TUBING PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Kroy Medical, Inc.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K913363. 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 TUBING PACKS?

CUSTOM TUBING PACKS is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is Kroy Medical, Inc.. The 510(k) number is K913363.

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

CUSTOM TUBING PACKS received FDA 510(k) clearance on 1991-12-20, under 510(k) number K913363.

Who is the listed applicant for CUSTOM TUBING PACKS?

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

What is the FDA product code for CUSTOM TUBING PACKS?

The FDA product code for CUSTOM TUBING 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

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.

↑