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FDA 510(k)

UNIVERSAL TERMINAL CAP, 3.2MM

K-Number: K913919 · 1991-12-31

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1991-12-31
Product CodeKFJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TERMINAL CAP, 3.2MM 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 1991-12-31 under 510(k) number K913919. 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 UNIVERSAL TERMINAL CAP, 3.2MM?

UNIVERSAL TERMINAL CAP, 3.2MM is a medical device that received FDA 510(k) clearance on 1991-12-31. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K913919.

When did UNIVERSAL TERMINAL CAP, 3.2MM receive FDA 510(k) clearance?

UNIVERSAL TERMINAL CAP, 3.2MM received FDA 510(k) clearance on 1991-12-31, under 510(k) number K913919.

Who is the listed applicant for UNIVERSAL TERMINAL CAP, 3.2MM?

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 UNIVERSAL TERMINAL CAP, 3.2MM?

The FDA product code for UNIVERSAL TERMINAL CAP, 3.2MM is KFJ.

Related Clinical Trials

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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 MMK926340NEW LEAD INTRODUCER KITS, VARIOUS MODELSK914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBINGK912773UNIPOLAR UPSIZING ADAPTOR

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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.

K852236MEDTRONIC MODEL 5867-1AMedtronic VascularK813518IMPLANT AID SPLICING CRIMP & SLEEVEIntermedics, Inc.

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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