Who else makes this device?

Name: Edwards Dilator KIT
Brand: Edwards Dilator KIT

Cardiovascular › DiagnosticDilator, Vessel, For Percutaneous Catheterization

Edwards Dilator KIT

Catalogue number 9100DKSA, listed by Edwards Lifesciences Technology Sarl, United States, under Dilator, Vessel, For Percutaneous Catheterization. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 Edwards Dilator KIT
Listed by	Edwards Lifesciences Technology Sarl, United States
FDA product code	DRE
Device type	Dilator, Vessel, For Percutaneous Catheterization
Device class	Class 2
Regulation	21 CFR 870.1310
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2015-12-01
Record revised	2024-03-20 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Special storage condition: STORE IN A COOL, DRY PLACE

Catalogue Numbers

Catalogue numbers for Edwards Dilator KIT
Catalogue number	Size	Status
9100DKSA	22 FRENCH	In distribution

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
K093554	2010-04-13

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.