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FDA 510(k)

MODIFICATION TO VIKING OPTIMA GUIDING CATHETER

K-Number: K013638 · 2001-12-04

ApplicantGuidant Corp.
Decision Date2001-12-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VIKING OPTIMA GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2001-12-04 under 510(k) number K013638. 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 MODIFICATION TO VIKING OPTIMA GUIDING CATHETER?

MODIFICATION TO VIKING OPTIMA GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2001-12-04. The listed applicant is Guidant Corp.. The 510(k) number is K013638.

When did MODIFICATION TO VIKING OPTIMA GUIDING CATHETER receive FDA 510(k) clearance?

MODIFICATION TO VIKING OPTIMA GUIDING CATHETER received FDA 510(k) clearance on 2001-12-04, under 510(k) number K013638.

Who is the listed applicant for MODIFICATION TO VIKING OPTIMA GUIDING CATHETER?

The FDA 510(k) record lists Guidant Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO VIKING OPTIMA GUIDING CATHETER?

The FDA product code for MODIFICATION TO VIKING OPTIMA GUIDING CATHETER is DQY.

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Other records listing Guidant Corp. as applicant

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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

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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