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FDA 510(k)

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE

K-Number: K030617 · 2003-05-21

ApplicantBoston Scientific Scimed, Inc.
Decision Date2003-05-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K030617. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K030617.

When did PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE receive FDA 510(k) clearance?

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE received FDA 510(k) clearance on 2003-05-21, under 510(k) number K030617.

Who is the listed applicant for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

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

What is the FDA product code for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

The FDA product code for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE is DQX.

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Other records listing Boston Scientific Scimed, Inc. as applicant

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K041727MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456K024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEMK021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETERK021901WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMK012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXXK012216NIROYAL BILIARY PREMOUNTED STENT SYSTEM

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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