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FDA 510(k)

SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS

K-Number: K913830 · 1991-11-22

ApplicantScimed Life Systems, Inc.
Decision Date1991-11-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS 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 1991-11-22 under 510(k) number K913830. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS?

SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K913830.

When did SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS receive FDA 510(k) clearance?

SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913830.

Who is the listed applicant for SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS?

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 8 FR. TRIGUIDEFLEX GUIDING CATHETERS?

The FDA product code for SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS is DQY.

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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: DQY)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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