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FDA 510(k)

CORDIPAK CARDIAC CATHETERIZATION PACK

K-Number: K863337 · 1986-09-29

ApplicantAngi-Pak Corp.
Decision Date1986-09-29
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIPAK CARDIAC CATHETERIZATION PACK is the device name listed in this FDA 510(k) record. The listed applicant is Angi-Pak Corp.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863337. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIPAK CARDIAC CATHETERIZATION PACK?

CORDIPAK CARDIAC CATHETERIZATION PACK is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Angi-Pak Corp.. The 510(k) number is K863337.

When did CORDIPAK CARDIAC CATHETERIZATION PACK receive FDA 510(k) clearance?

CORDIPAK CARDIAC CATHETERIZATION PACK received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863337.

Who is the listed applicant for CORDIPAK CARDIAC CATHETERIZATION PACK?

The FDA 510(k) record lists Angi-Pak Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDIPAK CARDIAC CATHETERIZATION PACK?

The FDA product code for CORDIPAK CARDIAC CATHETERIZATION PACK is DQO.

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 Angi-Pak Corp. 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.

K863336CORDIPAK ANGIOGRAPHY TRAY

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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