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FDA 510(k)

BIOTRONIK I-UNIPOLAR PE-60/2-13

K-Number: K833108 · 1983-10-19

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

Device Summary

BIOTRONIK I-UNIPOLAR PE-60/2-13 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 K833108. 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 I-UNIPOLAR PE-60/2-13?

BIOTRONIK I-UNIPOLAR PE-60/2-13 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 K833108.

When did BIOTRONIK I-UNIPOLAR PE-60/2-13 receive FDA 510(k) clearance?

BIOTRONIK I-UNIPOLAR PE-60/2-13 received FDA 510(k) clearance on 1983-10-19, under 510(k) number K833108.

Who is the listed applicant for BIOTRONIK I-UNIPOLAR PE-60/2-13?

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 I-UNIPOLAR PE-60/2-13?

The FDA product code for BIOTRONIK I-UNIPOLAR PE-60/2-13 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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