FlexCath Cross Transseptal Solution

FlexCath Cross Transseptal Solution– VZ 71 cm

Registry build 21.09.26
1manufacturer
6catalogue numbers in this listing

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 FlexCath Cross Transseptal Solution
Listed by Acutus Medical, 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 2023-09-01

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for FlexCath Cross Transseptal Solution
Catalogue number Size Status
900303-003 In distribution
900308-003 In distribution
900301-003 In distribution
900300-003 In distribution
900306-003 In distribution
900302-003 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer