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FDA 510(k)

IMPLANTAID LEAD INTRODUCER #319-10 & 12

K-Number: K812502 · 1981-10-13

ApplicantIntermedics, Inc.
Decision Date1981-10-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANTAID LEAD INTRODUCER #319-10 & 12 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812502. 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 IMPLANTAID LEAD INTRODUCER #319-10 & 12?

IMPLANTAID LEAD INTRODUCER #319-10 & 12 is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Intermedics, Inc.. The 510(k) number is K812502.

When did IMPLANTAID LEAD INTRODUCER #319-10 & 12 receive FDA 510(k) clearance?

IMPLANTAID LEAD INTRODUCER #319-10 & 12 received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812502.

Who is the listed applicant for IMPLANTAID LEAD INTRODUCER #319-10 & 12?

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

What is the FDA product code for IMPLANTAID LEAD INTRODUCER #319-10 & 12?

The FDA product code for IMPLANTAID LEAD INTRODUCER #319-10 & 12 is DYB.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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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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