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FDA 510(k)

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES

K-Number: K931662 · 1993-08-31

ApplicantPace Medical
Decision Date1993-08-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1993-08-31 under 510(k) number K931662. 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 LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES?

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES is a medical device that received FDA 510(k) clearance on 1993-08-31. The listed applicant is Pace Medical. The 510(k) number is K931662.

When did LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES receive FDA 510(k) clearance?

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES received FDA 510(k) clearance on 1993-08-31, under 510(k) number K931662.

Who is the listed applicant for LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES?

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

What is the FDA product code for LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES?

The FDA product code for LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES is DYB.

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Other records listing Pace Medical 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.

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK002496MODEL 4815 ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

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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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