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FDA 510(k)

APC IMPLANTABLE PACING LEADS

K-Number: K812807 · 1982-01-18

ApplicantAmerican Pacemaker Corp.
Decision Date1982-01-18
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APC IMPLANTABLE PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is American Pacemaker Corp.. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K812807. 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 APC IMPLANTABLE PACING LEADS?

APC IMPLANTABLE PACING LEADS is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is American Pacemaker Corp.. The 510(k) number is K812807.

When did APC IMPLANTABLE PACING LEADS receive FDA 510(k) clearance?

APC IMPLANTABLE PACING LEADS received FDA 510(k) clearance on 1982-01-18, under 510(k) number K812807.

Who is the listed applicant for APC IMPLANTABLE PACING LEADS?

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

What is the FDA product code for APC IMPLANTABLE PACING LEADS?

The FDA product code for APC IMPLANTABLE PACING LEADS is DTB.

Related Clinical Trials

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.

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Other records listing American Pacemaker Corp. 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.

K821791EXTERNAL PULSE GENERATOR - EV4542K812830APC IMPLANTABLE PACING LEADK810399APC IMPLANTABEL PACING LEAD, MODEL 3264K810397APC IMPLANTABLE PACING LEAD-FLANGE #3260K810396APC IMPLANTABLE PACING LEAD, TINED #3262K810398APC IMPLANTABLE PACING LEAD, MODEL 3266

View all 14 devices →

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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