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FDA 510(k)

IMPLANTABLE ENDOCARDIAL PACING LEADS

K-Number: K831926 · 1984-03-12

ApplicantOscor, Inc.
Decision Date1984-03-12
Product CodeDTG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE ENDOCARDIAL PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K831926. The device is classified under product code DTG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE ENDOCARDIAL PACING LEADS?

IMPLANTABLE ENDOCARDIAL PACING LEADS is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Oscor, Inc.. The 510(k) number is K831926.

When did IMPLANTABLE ENDOCARDIAL PACING LEADS receive FDA 510(k) clearance?

IMPLANTABLE ENDOCARDIAL PACING LEADS received FDA 510(k) clearance on 1984-03-12, under 510(k) number K831926.

Who is the listed applicant for IMPLANTABLE ENDOCARDIAL PACING LEADS?

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 IMPLANTABLE ENDOCARDIAL PACING LEADS?

The FDA product code for IMPLANTABLE ENDOCARDIAL PACING LEADS is DTG.

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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: DTG)

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.

K092364MODEL 220 PATIENT MAGNETCyberonics, Inc.K960849MAGNO ALARMCardiac Assist Devices, Inc.K895110MAESTRO PACEMAKER TEST MAGNETCardiac Control Systems, Inc.K813153TEST MAGNETPacesetter Systems

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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