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FDA 510(k)

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

K-Number: K930348 · 1993-09-03

ApplicantBoston Scientific Corp
Decision Date1993-09-03
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1993-09-03 under 510(k) number K930348. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM?

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K930348.

When did COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM receive FDA 510(k) clearance?

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM received FDA 510(k) clearance on 1993-09-03, under 510(k) number K930348.

Who is the listed applicant for COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM?

The FDA product code for COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM is FDX.

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Related Devices (Code: FDX)

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.

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems CorporationK220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook IncorporatedK182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, 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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