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FDA 510(k)

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)

K-Number: K862966 · 1986-10-31

ApplicantOscor Medical Corp.
Decision Date1986-10-31
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Oscor Medical Corp.. It received FDA 510(k) clearance on 1986-10-31 under 510(k) number K862966. 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 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)?

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) is a medical device that received FDA 510(k) clearance on 1986-10-31. The listed applicant is Oscor Medical Corp.. The 510(k) number is K862966.

When did 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) receive FDA 510(k) clearance?

3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) received FDA 510(k) clearance on 1986-10-31, under 510(k) number K862966.

Who is the listed applicant for 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)?

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

What is the FDA product code for 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)?

The FDA product code for 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) is DTB.

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Other records listing Oscor Medical Corp. 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.

K964107OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PRK925168MISCELLANEOUS PACING LEADK923621EXTERNAL DEMAND PACEMAKERK912867OSCOR MEDICAL CORP PERMANENT PACING LEADK915008PERMANENT PACING PAD, MODIFICATIONK915007PERMANENT PACING LEADS, MODIFICATION

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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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