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FDA 510(k)

BIOTRONIK D2K UNIPOLAR PE-60/4

K-Number: K833104 · 1983-10-19

ApplicantBiotronik Sales, Inc.
Decision Date1983-10-19
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTRONIK D2K UNIPOLAR PE-60/4 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik Sales, Inc.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K833104. 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 BIOTRONIK D2K UNIPOLAR PE-60/4?

BIOTRONIK D2K UNIPOLAR PE-60/4 is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K833104.

When did BIOTRONIK D2K UNIPOLAR PE-60/4 receive FDA 510(k) clearance?

BIOTRONIK D2K UNIPOLAR PE-60/4 received FDA 510(k) clearance on 1983-10-19, under 510(k) number K833104.

Who is the listed applicant for BIOTRONIK D2K UNIPOLAR PE-60/4?

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

What is the FDA product code for BIOTRONIK D2K UNIPOLAR PE-60/4?

The FDA product code for BIOTRONIK D2K UNIPOLAR PE-60/4 is DTB.

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Other records listing Biotronik Sales, 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.

K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORK853194ERA-20K860036EDP-20 PACEMAKERK863878TRIOS-M VS-1 PULSE GENERATORK863879NEOS-M VS-1 PULSE GENERATORK863480BIOTRONIK PERMANENT PACEMAKER ELECTRODE

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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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