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FDA 510(k)

NEW LEAD INTRODUCER KITS, VARIOUS MODELS

K-Number: K926340 · 1993-05-27

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1993-05-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEW LEAD INTRODUCER KITS, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics Pacing Systems, Inc.. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K926340. 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 NEW LEAD INTRODUCER KITS, VARIOUS MODELS?

NEW LEAD INTRODUCER KITS, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K926340.

When did NEW LEAD INTRODUCER KITS, VARIOUS MODELS receive FDA 510(k) clearance?

NEW LEAD INTRODUCER KITS, VARIOUS MODELS received FDA 510(k) clearance on 1993-05-27, under 510(k) number K926340.

Who is the listed applicant for NEW LEAD INTRODUCER KITS, VARIOUS MODELS?

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

What is the FDA product code for NEW LEAD INTRODUCER KITS, VARIOUS MODELS?

The FDA product code for NEW LEAD INTRODUCER KITS, VARIOUS MODELS is DYB.

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Other records listing Telectronics Pacing Systems, 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.

K961118MAXIM PF MODELS 033-581/033-590K943657STERILIZATIONK934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MMK914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBINGK913919UNIVERSAL TERMINAL CAP, 3.2MMK912773UNIPOLAR UPSIZING ADAPTOR

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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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