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FDA 510(k)

BYRD STAINLESS STEEL DILATOR

K-Number: K902502 · 1990-08-07

ApplicantMedical Engineering and Development Institute
Decision Date1990-08-07
Product CodeGCC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRD STAINLESS STEEL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering and Development Institute. It received FDA 510(k) clearance on 1990-08-07 under 510(k) number K902502. 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 STAINLESS STEEL DILATOR?

BYRD STAINLESS STEEL DILATOR is a medical device that received FDA 510(k) clearance on 1990-08-07. The listed applicant is Medical Engineering and Development Institute. The 510(k) number is K902502.

When did BYRD STAINLESS STEEL DILATOR receive FDA 510(k) clearance?

BYRD STAINLESS STEEL DILATOR received FDA 510(k) clearance on 1990-08-07, under 510(k) number K902502.

Who is the listed applicant for BYRD STAINLESS STEEL DILATOR?

The FDA 510(k) record lists Medical Engineering and Development Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BYRD STAINLESS STEEL DILATOR?

The FDA product code for BYRD STAINLESS STEEL DILATOR is GCC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Engineering and Development Institute 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.

K902477WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SETK902469BYRD DILATOR SHEATH SET - TEFLONK895030LIFE-LINE(TM) VASCULAR ACCESS SYSTEMK893480BYRD EXTRACTOR SETK890820LOCKING WIRE GUIDE STYLET

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.K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SETMed Institute, Inc.K893480BYRD 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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