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FDA 510(k)

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET

K-Number: K922354 · 1992-07-30

ApplicantMed Institute, Inc.
Decision Date1992-07-30
Product CodeGCC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET 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 1992-07-30 under 510(k) number K922354. 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 BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET?

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Med Institute, Inc.. The 510(k) number is K922354.

When did BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET receive FDA 510(k) clearance?

BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET received FDA 510(k) clearance on 1992-07-30, under 510(k) number K922354.

Who is the listed applicant for BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET?

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 BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET?

The FDA product code for BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET 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 CATHETERK981061INTRAVASCULAR RETRIEVAL DEVICEK964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEMK971140VITAL-PORT INFUSION PALK970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEM

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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.

K981061INTRAVASCULAR RETRIEVAL DEVICEMed 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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