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FDA 510(k)

PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290

K-Number: K864153 · 1987-01-06

ApplicantPace Medical
Decision Date1987-01-06
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K864153. 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 PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290?

PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Pace Medical. The 510(k) number is K864153.

When did PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 receive FDA 510(k) clearance?

PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 received FDA 510(k) clearance on 1987-01-06, under 510(k) number K864153.

Who is the listed applicant for PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290?

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

What is the FDA product code for PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290?

The FDA product code for PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 is DTB.

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Other records listing Pace Medical 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.

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VK002496MODEL 4815 ADAPTERK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

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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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