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FDA 510(k)

PERCUTANEOUS CATHETER INTRODUCER SET

K-Number: K822593 · 1982-09-28

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

Device Summary

PERCUTANEOUS CATHETER INTRODUCER SET 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 K822593. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS CATHETER INTRODUCER SET?

PERCUTANEOUS CATHETER INTRODUCER SET 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 K822593.

When did PERCUTANEOUS CATHETER INTRODUCER SET receive FDA 510(k) clearance?

PERCUTANEOUS CATHETER INTRODUCER SET received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822593.

Who is the listed applicant for PERCUTANEOUS CATHETER INTRODUCER SET?

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 PERCUTANEOUS CATHETER INTRODUCER SET?

The FDA product code for PERCUTANEOUS CATHETER INTRODUCER SET is DYB.

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Other records listing Vertex Medical 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.

K833742ESCHMANN DILATION CATHETERK834476NEPHROSTOMY/BILIARY DRAINAGE BAGK832380PROTECTIVE SLEEVEK831666SIALOGRAPHY NEEDLEK830576LYMPHANGIOGRAPHY SETK830420POLYETHYLENE MONITORING CONNECTORS

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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