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FDA 510(k)

MODIFIED CATHETER PACKAGE

K-Number: K800703 · 1980-04-08

ApplicantHancock Laboratories, Inc.
Decision Date1980-04-08
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED CATHETER PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Hancock Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800703. 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 MODIFIED CATHETER PACKAGE?

MODIFIED CATHETER PACKAGE is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Hancock Laboratories, Inc.. The 510(k) number is K800703.

When did MODIFIED CATHETER PACKAGE receive FDA 510(k) clearance?

MODIFIED CATHETER PACKAGE received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800703.

Who is the listed applicant for MODIFIED CATHETER PACKAGE?

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

What is the FDA product code for MODIFIED CATHETER PACKAGE?

The FDA product code for MODIFIED CATHETER PACKAGE 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 Hancock Laboratories, 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.

K801885HANCOCK * OBTURATORSK800122HANCOCK AORTIC PUNCHK790534MERSILENE SUTURESK780568DURAN FLEXIBLE RING

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

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