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FDA 510(k)

COAXIAL BIPOLAR PACING ELECTRODE

K-Number: K822239 · 1982-10-04

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1982-10-04
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COAXIAL BIPOLAR PACING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K822239. 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 COAXIAL BIPOLAR PACING ELECTRODE?

COAXIAL BIPOLAR PACING ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K822239.

When did COAXIAL BIPOLAR PACING ELECTRODE receive FDA 510(k) clearance?

COAXIAL BIPOLAR PACING ELECTRODE received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822239.

Who is the listed applicant for COAXIAL BIPOLAR PACING ELECTRODE?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAXIAL BIPOLAR PACING ELECTRODE?

The FDA product code for COAXIAL BIPOLAR PACING ELECTRODE is DTB.

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Other records listing Burditt & Calkins-Siemens-Elema 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.

K833519PULSE GENERATOR MODEL 688K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORDK830344SIEMENS-ELMA PULSE GENERATOR #718K823435MON-A-THERM MYOCARDIAL TEMP. SENSORK823591AMEDA HAND BREAST PUMPK821712INFORMED REMOTE FIELD UNIT MODEL IFM1000

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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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