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FDA 510(k)

LEAD TERMINAL PIN CAPS, VARIOUS MODELS

K-Number: K911142 · 1991-08-09

ApplicantBiotronik, GmbH & Co.
Decision Date1991-08-09
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD TERMINAL PIN CAPS, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K911142. 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 LEAD TERMINAL PIN CAPS, VARIOUS MODELS?

LEAD TERMINAL PIN CAPS, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K911142.

When did LEAD TERMINAL PIN CAPS, VARIOUS MODELS receive FDA 510(k) clearance?

LEAD TERMINAL PIN CAPS, VARIOUS MODELS received FDA 510(k) clearance on 1991-08-09, under 510(k) number K911142.

Who is the listed applicant for LEAD TERMINAL PIN CAPS, VARIOUS MODELS?

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

What is the FDA product code for LEAD TERMINAL PIN CAPS, VARIOUS MODELS?

The FDA product code for LEAD TERMINAL PIN CAPS, VARIOUS MODELS is DTD.

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Other records listing Biotronik, GmbH & Co. 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.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERK922742HPM 40 HEART PACEMAKER MONITORK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

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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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