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FDA 510(k)

BIOTRONIK DY-UNIPOLAR

K-Number: K841451 · 1985-02-07

ApplicantBiotronik Sales, Inc.
Decision Date1985-02-07
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTRONIK DY-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 1985-02-07 under 510(k) number K841451. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRONIK DY-UNIPOLAR?

BIOTRONIK DY-UNIPOLAR is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K841451.

When did BIOTRONIK DY-UNIPOLAR receive FDA 510(k) clearance?

BIOTRONIK DY-UNIPOLAR received FDA 510(k) clearance on 1985-02-07, under 510(k) number K841451.

Who is the listed applicant for BIOTRONIK DY-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 BIOTRONIK DY-UNIPOLAR?

The FDA product code for BIOTRONIK DY-UNIPOLAR is DTD.

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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: DTD)

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.

K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant CorporationK031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, 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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