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FDA 510(k)

SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY

K-Number: K931514 · 1993-06-25

ApplicantScimed Life Systems, Inc.
Decision Date1993-06-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1993-06-25 under 510(k) number K931514. 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 SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY?

SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY is a medical device that received FDA 510(k) clearance on 1993-06-25. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K931514.

When did SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY receive FDA 510(k) clearance?

SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY received FDA 510(k) clearance on 1993-06-25, under 510(k) number K931514.

Who is the listed applicant for SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY?

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

What is the FDA product code for SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY?

The FDA product code for SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY is DQX.

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Other records listing Scimed Life Systems, 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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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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