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FDA 510(k)

GUIDE CATHETERS AND ACCESSORIES

K-Number: K101015 · 2010-09-23

ApplicantThomas Medical Products, Inc.
Decision Date2010-09-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDE CATHETERS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Thomas Medical Products, Inc.. It received FDA 510(k) clearance on 2010-09-23 under 510(k) number K101015. 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 GUIDE CATHETERS AND ACCESSORIES?

GUIDE CATHETERS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2010-09-23. The listed applicant is Thomas Medical Products, Inc.. The 510(k) number is K101015.

When did GUIDE CATHETERS AND ACCESSORIES receive FDA 510(k) clearance?

GUIDE CATHETERS AND ACCESSORIES received FDA 510(k) clearance on 2010-09-23, under 510(k) number K101015.

Who is the listed applicant for GUIDE CATHETERS AND ACCESSORIES?

The FDA 510(k) record lists Thomas Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUIDE CATHETERS AND ACCESSORIES?

The FDA product code for GUIDE CATHETERS AND ACCESSORIES is DQY.

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Other records listing Thomas Medical Products, 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.

K122431HEARTSPAN STEERABLE INTRODUCER KITK120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSK083269CROSSOVERK081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)K072745Y-GLIDEK043438LARGE BORE SPLITTABLE INTRODUCER KIT

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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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