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FDA 510(k)

STARCLOSE HEX-HUB DILATOR

K-Number: K062554 · 2007-02-06

ApplicantAbbott Vascular, Inc.
Decision Date2007-02-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STARCLOSE HEX-HUB DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular, Inc.. It received FDA 510(k) clearance on 2007-02-06 under 510(k) number K062554. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARCLOSE HEX-HUB DILATOR?

STARCLOSE HEX-HUB DILATOR is a medical device that received FDA 510(k) clearance on 2007-02-06. The listed applicant is Abbott Vascular, Inc.. The 510(k) number is K062554.

When did STARCLOSE HEX-HUB DILATOR receive FDA 510(k) clearance?

STARCLOSE HEX-HUB DILATOR received FDA 510(k) clearance on 2007-02-06, under 510(k) number K062554.

Who is the listed applicant for STARCLOSE HEX-HUB DILATOR?

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

What is the FDA product code for STARCLOSE HEX-HUB DILATOR?

The FDA product code for STARCLOSE HEX-HUB DILATOR is DRE.

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Other records listing Abbott Vascular, Inc. as applicant

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K123067PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILYK122573HI-TORQUE COMMAND GUIDE WIRE FAMILYK102705ARMADA 14 PTA CATHETERK101648HI-TORQUE WINN GUIDE WIRE FAMILYK101011HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALK091825HI-TORQUE PROGRESS GUIDE WIRE FAMILY

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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