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FDA 510(k)

DNR UNIPOLAR

K-Number: K853568 · 1986-01-15

ApplicantBiotronik Sales, Inc.
Decision Date1986-01-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DNR UNIPOLAR 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 1986-01-15 under 510(k) number K853568. 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 DNR UNIPOLAR?

DNR UNIPOLAR is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K853568.

When did DNR UNIPOLAR receive FDA 510(k) clearance?

DNR UNIPOLAR received FDA 510(k) clearance on 1986-01-15, under 510(k) number K853568.

Who is the listed applicant for DNR UNIPOLAR?

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 DNR UNIPOLAR?

The FDA product code for DNR UNIPOLAR is DTB.

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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 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 PACEMAKERK863879NEOS-M VS-1 PULSE GENERATORK863878TRIOS-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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