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FDA 510(k)

OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF

K-Number: K913205 · 1991-09-23

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

Device Summary

OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF 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 K913205. 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 OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF?

OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF 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 K913205.

When did OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF receive FDA 510(k) clearance?

OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF received FDA 510(k) clearance on 1991-09-23, under 510(k) number K913205.

Who is the listed applicant for OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF?

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 OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF?

The FDA product code for OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF 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

View all 31 devices →

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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