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FDA 510(k)

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP

K-Number: K813134 · 1981-12-10

ApplicantTelectronics, Inc.
Decision Date1981-12-10
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1981-12-10 under 510(k) number K813134. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP?

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP is a medical device that received FDA 510(k) clearance on 1981-12-10. The listed applicant is Telectronics, Inc.. The 510(k) number is K813134.

When did ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP receive FDA 510(k) clearance?

ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP received FDA 510(k) clearance on 1981-12-10, under 510(k) number K813134.

Who is the listed applicant for ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP?

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

What is the FDA product code for ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP?

The FDA product code for ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP is DTB.

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Other records listing Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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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