Profile 3d™

Handle 7686XL Annuloplasty MDR

Registry build 21.09.26
1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code DTJ
Manufacturer City Province Registered as Device types
Beijing Hangtian Kadi Technology R&D Institute Beijing Beijing Manufacturer 5

Record

Regulatory record for Profile 3D™
Listed by Medtronic, Inc., United States
FDA product code DTJ
Device type Holder, Heart-Valve, Prosthesis
Device class Class 1
Regulation 21 CFR 870.3935
Establishment Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2025-07-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Sizes Length 216 to 373 mm

Catalogue Numbers

Catalogue numbers for Profile 3D™
Catalogue number Size Status
7686 Length 216.0 mm In distribution
7686XL Length 373.0 mm In distribution
7686L Length 254.0 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Holder, Heart-Valve, Prosthesis Medtronic, Inc. 10
Annuloplasty Handle Medtronic, Inc. 8
Valve Handle Medtronic, Inc. 4
Masters Series™ St. Jude Medical 3
SJM™ St. Jude Medical 3
Open Pivot™ Medtronic, Inc. 2
Heart Valve Accessor Edwards Lifesciences Technology Sarl 2
Avalus™ Medtronic, Inc. 2
Mitris Handle 1140M Edwards Lifesciences Technology Sarl 1
Flexible Handle Edwards Lifesciences Technology Sarl 1
A Handle Compatible With Ring Holders Models 5100, 4900, 4100, 4200, 4450 AND 46 Edwards Lifesciences Technology Sarl 1
Valve Handle 7420 Medtronic, Inc. 1

Showing 12 of 18. All products under Holder, Heart-Valve, Prosthesis

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