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FDA 510(k)

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER

K-Number: K861951 · 1986-06-19

ApplicantTeleflex, Inc.
Decision Date1986-06-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex, Inc.. It received FDA 510(k) clearance on 1986-06-19 under 510(k) number K861951. 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 MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER?

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER is a medical device that received FDA 510(k) clearance on 1986-06-19. The listed applicant is Teleflex, Inc.. The 510(k) number is K861951.

When did MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER receive FDA 510(k) clearance?

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER received FDA 510(k) clearance on 1986-06-19, under 510(k) number K861951.

Who is the listed applicant for MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER?

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

What is the FDA product code for MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER?

The FDA product code for MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER is DYB.

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.

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Other records listing Teleflex, 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.

K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetK123974PERCUTANEOUS INTRODUCER KITK121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETK103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERK860307PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET

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

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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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