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FDA 510(k)

APC IMPLANTABEL PACING LEAD, MODEL 3264

K-Number: K810399 · 1981-05-15

ApplicantAmerican Pacemaker Corp.
Decision Date1981-05-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APC IMPLANTABEL PACING LEAD, MODEL 3264 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 1981-05-15 under 510(k) number K810399. 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 IMPLANTABEL PACING LEAD, MODEL 3264?

APC IMPLANTABEL PACING LEAD, MODEL 3264 is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is American Pacemaker Corp.. The 510(k) number is K810399.

When did APC IMPLANTABEL PACING LEAD, MODEL 3264 receive FDA 510(k) clearance?

APC IMPLANTABEL PACING LEAD, MODEL 3264 received FDA 510(k) clearance on 1981-05-15, under 510(k) number K810399.

Who is the listed applicant for APC IMPLANTABEL PACING LEAD, MODEL 3264?

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 IMPLANTABEL PACING LEAD, MODEL 3264?

The FDA product code for APC IMPLANTABEL PACING LEAD, MODEL 3264 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 LEADK812807APC IMPLANTABLE PACING LEADSK810396APC IMPLANTABLE PACING LEAD, TINED #3262K810397APC IMPLANTABLE PACING LEAD-FLANGE #3260K810398APC 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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