Gelbfish Flex Vascular Dilator

Q: What is the product code of K030260?

The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.

FDA 510(k) K030260 · Vascumetrix, LLC

Substantially Equivalent

510(k) numberK030260

Submission

Device name: Gelbfish Flex Vascular Dilator
Applicant: Vascumetrix, LLC
Mesa, AZ, US
Received: January 24, 2003
Decision date: February 20, 2003
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DRE – Dilator, Vessel, For Percutaneous Catheterization
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1310
Specialty: Cardiovascular

Other 510(k)s with product code DRE

510(k)	Device	Applicant	Decision
K261310	FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional	Merit Medical Systems, Inc.	07/27/2026SE
K253616	ProtekDilate Vascular Access KitDRE · Special	Sorin Group Italia S.R.L.	12/19/2025SE
K251325	VersaCross Connect Transseptal DilatorDRE · Special	Baylis Medical Company, Inc.	05/29/2025SE
K242229	Micro Ace Gold Advanced Micro Access SystemDRE · Traditional	Merit Medical Systems, Inc.	01/15/2025SE
K241720	VersaCross Connect Transseptal DilatorDRE · Special	Baylis Medical Company, Inc.	07/12/2024SE
K233647	VersaCross Connect Transseptal DilatorDRE · Special	Baylis Medical Company, Inc.	12/14/2023SE
K232609	Micro Ace Advanced Micro Access SystemDRE · Special	Merit Medical Systems, Inc.	09/27/2023SE
K223472	TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special	Spectranetics, Inc.	12/15/2022SE
K212784	TightRail Guardian Motorized Dilator SheathDRE · Traditional	Spectranetics, Inc.	08/24/2022SE
K211679	Xtractor deviceDRE · Traditional	Xcardia Innovation , Ltd.	02/17/2022SE

More from Xcardia Innovation , Ltd.

510(k)	Device	Decision
K023507	Modification to Gelbfish Vascular DilatorsDRE · Special	11/08/2002SE
K012256	Gelbish Vascular DilatorDRE · Traditional	12/20/2001SE

Questions and answers

When was Gelbfish Flex Vascular Dilator cleared by the FDA?

Gelbfish Flex Vascular Dilator (K030260) received a 510(k) decision of Substantially Equivalent on February 20, 2003, 27 days after the submission was received.

What is the product code of K030260?

The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.