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FDA 510(k)

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

K-Number: K010787 · 2001-05-22

ApplicantOscor, Inc.
Decision Date2001-05-22
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2001-05-22 under 510(k) number K010787. 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 PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS?

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS is a medical device that received FDA 510(k) clearance on 2001-05-22. The listed applicant is Oscor, Inc.. The 510(k) number is K010787.

When did PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS receive FDA 510(k) clearance?

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS received FDA 510(k) clearance on 2001-05-22, under 510(k) number K010787.

Who is the listed applicant for PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS?

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

What is the FDA product code for PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS?

The FDA product code for PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS is DTD.

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Other records listing Oscor, Inc. as applicant

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K210627Breezeway IIK130104GUIDEWIRE, PURSUER SERIESK122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYK122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK122084INTRODUCER SET, MODEL ADELANTE-S SERIESK120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

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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.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, Inc.K000210MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KITMedtronic Vascular

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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