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FDA 510(k)

MODEL SF. D&SX.D PACEMAKER LEADS

K-Number: K823897 · 1983-04-30

ApplicantOscor, Inc.
Decision Date1983-04-30
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SF. D&SX.D PACEMAKER 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 1983-04-30 under 510(k) number K823897. 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 MODEL SF. D&SX.D PACEMAKER LEADS?

MODEL SF. D&SX.D PACEMAKER LEADS is a medical device that received FDA 510(k) clearance on 1983-04-30. The listed applicant is Oscor, Inc.. The 510(k) number is K823897.

When did MODEL SF. D&SX.D PACEMAKER LEADS receive FDA 510(k) clearance?

MODEL SF. D&SX.D PACEMAKER LEADS received FDA 510(k) clearance on 1983-04-30, under 510(k) number K823897.

Who is the listed applicant for MODEL SF. D&SX.D PACEMAKER 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 MODEL SF. D&SX.D PACEMAKER LEADS?

The FDA product code for MODEL SF. D&SX.D PACEMAKER LEADS is DTB.

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Other records listing Oscor, 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.

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: 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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