Who else makes this device?

Name: ProtekDuo
Brand: ProtekDuo

ProtekDuo · Dilator, Vessel, for Percutaneous Catheterization → Cardiovascular

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code DRE
Manufacturer	City	Province	Registered as	Device types
Lifetech Scientific (Shenzhen) Co,.ltd	Shenzhen	Guangdong	Manufacturer	3

Record

Regulatory record for ProtekDuo
Listed by	Cardiacassist, Inc., United States
FDA product code	DRE
Device type	Dilator, Vessel, For Percutaneous Catheterization
Device class	Class 2
Regulation	21 CFR 870.1310
Record published	2018-10-08
Record revised	2025-08-26 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Distribution end date	2025-01-14

Catalogue Numbers

Catalogue numbers for ProtekDuo
Catalogue number	Size	Status
5720-3631		Withdrawn
5100-1426		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prelude®	Merit Medical Systems, Inc.	323
Prelude PRO™	Merit Medical Systems, Inc.	132
Cook	Cook Incorporated	125
Avanti	Cordis Corp.	81
Dilator, Vessel, For Percutaneous Catheterization	B. Braun Interventional Systems, Inc.	59
Merit MAK™	Merit Medical Systems, Inc.	49
Prelude ACT™	Merit Medical Systems, Inc.	38
AngioDynamics	Navilyst Medical, Inc.	38
Super Sheath	Togo Medikit Co., Ltd.	31
Avanti	Cordis US Corp.	29
Mini Stick MAX	AngioDynamics, Inc.	28
OneStic Micro-Access Introducer	Argon Medical Devices, Inc.	27

Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K162181	2017-01-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

ProtekDuo