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FDA 510(k)

TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS

K-Number: K822598 · 1982-09-28

ApplicantVertex Medical Corp.
Decision Date1982-09-28
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS is the device name listed in this FDA 510(k) record. The listed applicant is Vertex Medical Corp.. It received FDA 510(k) clearance on 1982-09-28 under 510(k) number K822598. 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 TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS?

TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Vertex Medical Corp.. The 510(k) number is K822598.

When did TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS receive FDA 510(k) clearance?

TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822598.

Who is the listed applicant for TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS?

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

What is the FDA product code for TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS?

The FDA product code for TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS is DQO.

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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

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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