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FDA 510(k)

INTRAVASCULAR RETRIEVAL DEVICE

K-Number: K981061 · 1998-05-26

ApplicantMed Institute, Inc.
Decision Date1998-05-26
Product CodeGCC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR RETRIEVAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 1998-05-26 under 510(k) number K981061. The device is classified under product code GCC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAVASCULAR RETRIEVAL DEVICE?

INTRAVASCULAR RETRIEVAL DEVICE is a medical device that received FDA 510(k) clearance on 1998-05-26. The listed applicant is Med Institute, Inc.. The 510(k) number is K981061.

When did INTRAVASCULAR RETRIEVAL DEVICE receive FDA 510(k) clearance?

INTRAVASCULAR RETRIEVAL DEVICE received FDA 510(k) clearance on 1998-05-26, under 510(k) number K981061.

Who is the listed applicant for INTRAVASCULAR RETRIEVAL DEVICE?

The FDA 510(k) record lists Med Institute, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAVASCULAR RETRIEVAL DEVICE?

The FDA product code for INTRAVASCULAR RETRIEVAL DEVICE is GCC.

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Other records listing Med Institute, Inc. 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.

K990034WILSON-COOK COLONIC Z-STENTK982507MINI POLYURETHANE CATHETERK964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEMK971140VITAL-PORT INFUSION PALK970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEMK945586FLEXIBLE DILATING SHEATH

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Related Devices (Code: GCC)

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.

K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SETMed Institute, Inc.K902502BYRD STAINLESS STEEL DILATORMedical Engineering and Development InstituteK893480BYRD EXTRACTOR SETMedical Engineering and Development InstituteK820865VAN-TEC FASCIAL DILATORVan-Tec, 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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