Vessel Dilator

FDA 510(k) K905416 · The R Group

Substantially Equivalent

510(k) numberK905416

Submission

Device name
Vessel Dilator
Applicant
The R Group
Gainesvilles, FL, US
Received
December 4, 1990
Decision date
March 25, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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)DeviceApplicantDecision
K261310FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional Merit Medical Systems, Inc.07/27/2026SE
K253616ProtekDilate Vascular Access KitDRE · Special Sorin Group Italia S.R.L.12/19/2025SE
K251325VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.05/29/2025SE
K242229Micro Ace Gold Advanced Micro Access SystemDRE · Traditional Merit Medical Systems, Inc.01/15/2025SE
K241720VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.07/12/2024SE
K233647VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.12/14/2023SE
K232609Micro Ace™ Advanced Micro Access SystemDRE · Special Merit Medical Systems, Inc.09/27/2023SE
K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special Spectranetics, Inc.12/15/2022SE
K212784TightRail Guardian Motorized Dilator SheathDRE · Traditional Spectranetics, Inc.08/24/2022SE
K211679Xtractor deviceDRE · Traditional Xcardia Innovation , Ltd.02/17/2022SE

More from Xcardia Innovation , Ltd.

510(k)DeviceDecision
K905415Braided High Pressure Catheter ConnectorFOZ · Traditional 08/12/1991SE
K912076Poly Braided Pigtail/Perc Card Cath W/Var Tip ConfDQO · Traditional 07/30/1991SE
K911549Injector Fill TubeDXT · Traditional 07/18/1991SE

Questions and answers

When was Vessel Dilator cleared by the FDA?

Vessel Dilator (K905416) received a 510(k) decision of Substantially Equivalent on March 25, 1991, 111 days after the submission was received.

What is the product code of K905416?

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