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FDA 510(k)

SCANLAN/TAHERI VALVULOTOME

K-Number: K911184 · 1992-02-18

ApplicantScanlan Intl., Inc.
Decision Date1992-02-18
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCANLAN/TAHERI VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K911184. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN/TAHERI VALVULOTOME?

SCANLAN/TAHERI VALVULOTOME is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K911184.

When did SCANLAN/TAHERI VALVULOTOME receive FDA 510(k) clearance?

SCANLAN/TAHERI VALVULOTOME received FDA 510(k) clearance on 1992-02-18, under 510(k) number K911184.

Who is the listed applicant for SCANLAN/TAHERI VALVULOTOME?

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

What is the FDA product code for SCANLAN/TAHERI VALVULOTOME?

The FDA product code for SCANLAN/TAHERI VALVULOTOME is MGZ.

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Other records listing Scanlan Intl., Inc. as applicant

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K960372SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEMK945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERK864920SCANLAN (TM) INSTRUMENT TRAYK864919SCANLAN (TM) VEIN/GRAFT HOLDERK851825SCANLAN TUNNELER, SHEATH & TIPK841521SCANLAN ENDARSECTOR

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Related Devices (Code: MGZ)

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.

K260188LimFlow VectorLimFlow, Inc.K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre VascularK132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, 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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