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FDA 510(k)

PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION

K-Number: K913201 · 1991-09-23

ApplicantOscor Medical Corp.
Decision Date1991-09-23
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION 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 1991-09-23 under 510(k) number K913201. 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 PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION?

PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Oscor Medical Corp.. The 510(k) number is K913201.

When did PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION receive FDA 510(k) clearance?

PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION received FDA 510(k) clearance on 1991-09-23, under 510(k) number K913201.

Who is the listed applicant for PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION?

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 PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION?

The FDA product code for PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION 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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