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FDA 510(k)

IMPLANT AID SPLICING CRIMP & SLEEVE

K-Number: K813518 · 1982-01-12

ApplicantIntermedics, Inc.
Decision Date1982-01-12
Product CodeKFJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANT AID SPLICING CRIMP & SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813518. The device is classified under product code KFJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT AID SPLICING CRIMP & SLEEVE?

IMPLANT AID SPLICING CRIMP & SLEEVE is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Intermedics, Inc.. The 510(k) number is K813518.

When did IMPLANT AID SPLICING CRIMP & SLEEVE receive FDA 510(k) clearance?

IMPLANT AID SPLICING CRIMP & SLEEVE received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813518.

Who is the listed applicant for IMPLANT AID SPLICING CRIMP & SLEEVE?

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 IMPLANT AID SPLICING CRIMP & SLEEVE?

The FDA product code for IMPLANT AID SPLICING CRIMP & SLEEVE is KFJ.

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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

View all 211 devices →

Related Devices (Code: KFJ)

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.

K913919UNIVERSAL TERMINAL CAP, 3.2MMTelectronics Pacing Systems, Inc.K852236MEDTRONIC MODEL 5867-1AMedtronic Vascular

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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