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FDA 510(k)

MODEL 2188 CORONARY SINUS LEAD.

K-Number: K961936 · 1996-08-15

ApplicantMedtronic Vascular
Decision Date1996-08-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL 2188 CORONARY SINUS LEAD. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K961936. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MODEL 2188 CORONARY SINUS LEAD.?

MODEL 2188 CORONARY SINUS LEAD. is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Medtronic Vascular. The 510(k) number is K961936.

When did MODEL 2188 CORONARY SINUS LEAD. receive FDA 510(k) clearance?

MODEL 2188 CORONARY SINUS LEAD. received FDA 510(k) clearance on 1996-08-15, under 510(k) number K961936.

Who is the listed applicant for MODEL 2188 CORONARY SINUS LEAD.?

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

What is the FDA product code for MODEL 2188 CORONARY SINUS LEAD.?

The FDA product code for MODEL 2188 CORONARY SINUS LEAD. is DTB.

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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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