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FDA 510(k)

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT

K-Number: K970341 · 1997-04-23

Decision Date1997-04-23
Product CodeLIS
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic PS Medical. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970341. The device is classified under product code LIS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT?

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Medtronic PS Medical. The 510(k) number is K970341.

When did MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT receive FDA 510(k) clearance?

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970341.

Who is the listed applicant for MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT?

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

What is the FDA product code for MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT?

The FDA product code for MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT is LIS.

Related Clinical Trials

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.

Other records listing Medtronic PS Medical 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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