Percutaneous Sheath W/Wo Medi. (5,6,7,8,8.5FR)

FDA 510(k) K870413 · Medical Surgical Concepts, Inc.

Substantially Equivalent

510(k) numberK870413

Submission

Device name
Percutaneous Sheath W/Wo Medi. (5,6,7,8,8.5FR)
Applicant
Medical Surgical Concepts, Inc.
Lansdale, PA, US
Received
February 3, 1987
Decision date
June 1, 1987
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
K870411Central Vein Catherization Kit W/Without Medica.DQY · Traditional 06/02/1987SE
K870412Triple Lumen Infusion Catheterization Set or KitDQY · Traditional 05/27/1987SE

Questions and answers

When was Percutaneous Sheath W/Wo Medi. (5,6,7,8,8.5FR) cleared by the FDA?

Percutaneous Sheath W/Wo Medi. (5,6,7,8,8.5FR) (K870413) received a 510(k) decision of Substantially Equivalent on June 1, 1987, 118 days after the submission was received.

What is the product code of K870413?

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