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FDA 510(k)

11F GUIDING CATHETER

K-Number: K963663 · 1997-01-13

ApplicantBoston Scientific /International Technologies
Decision Date1997-01-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

11F GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific /International Technologies. It received FDA 510(k) clearance on 1997-01-13 under 510(k) number K963663. 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 11F GUIDING CATHETER?

11F GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Boston Scientific /International Technologies. The 510(k) number is K963663.

When did 11F GUIDING CATHETER receive FDA 510(k) clearance?

11F GUIDING CATHETER received FDA 510(k) clearance on 1997-01-13, under 510(k) number K963663.

Who is the listed applicant for 11F GUIDING CATHETER?

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

What is the FDA product code for 11F GUIDING CATHETER?

The FDA product code for 11F GUIDING CATHETER is DQY.

Related Clinical Trials

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Other records listing Boston Scientific /International Technologies 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.

K971688IVT 0.014 PTFE-COATED TRACKWIREK954552RAILWIREK954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACKK930808PROTECTOR INTRODUCER SHEATH

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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