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FDA 510(k)

THE PILOT SCIMED TORQUE DEVICE

K-Number: K896108 · 1990-01-09

ApplicantScimed Life Systems, Inc.
Decision Date1990-01-09
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE PILOT SCIMED TORQUE DEVICE 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 1990-01-09 under 510(k) number K896108. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PILOT SCIMED TORQUE DEVICE?

THE PILOT SCIMED TORQUE DEVICE is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K896108.

When did THE PILOT SCIMED TORQUE DEVICE receive FDA 510(k) clearance?

THE PILOT SCIMED TORQUE DEVICE received FDA 510(k) clearance on 1990-01-09, under 510(k) number K896108.

Who is the listed applicant for THE PILOT SCIMED TORQUE DEVICE?

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 THE PILOT SCIMED TORQUE DEVICE?

The FDA product code for THE PILOT SCIMED TORQUE DEVICE is LOX.

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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: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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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