Who else makes this device?

Name: Achieve™
Brand: Achieve™

Achieve™ · Catheter, Electrode Recording, or Probe, Electrode Recording → Cardiovascular

5manufacturers in China registered for this device type

5catalogue numbers in this listing

5510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (2), Tianjin (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRF
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Palconn Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	4
Shanghai Microport EP Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	3

Record

Regulatory record for Achieve™
Listed by	Medtronic, Inc., United States
FDA product code	DRF
Device type	Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class	Class 2
Regulation	21 CFR 870.1220
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K102588
Record published	2016-04-07
Record revised	2018-07-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Storage	Handling environment temperature -35 to 58 °C; Special storage condition: Keep away from heat and sunlight; Storage environment temperature 15 to 30 °C; Storage environment humidity up to 85 % RH; Special storage condition: Keep Dry
Distribution end date	2018-06-21

Catalogue Numbers

Catalogue numbers for Achieve™
Catalogue number	Size	Status
990063-020	Overall Length 165 cm	In distribution
990063-015	Electrode Spacing 4 mm	In distribution
990063-020	Overall Length 165 cm	Withdrawn
990063-020	Overall Length 165 cm	Withdrawn
990063-015	Effective Length 146 cm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Map-iT	Access Point Medical, LLC	420
Woven	Boston Scientific Corporation	126
Inquiry™	Irvine Biomedical. Inc.	122
Webster	Biosense Webster, Inc.	121
Viking™	Boston Scientific Corporation	81
EasyFinder Fixed Curve Diagnostic Catheter	Shanghai Microport EP Medtech Co., Ltd.	56
Supreme™	St. Jude Medical Cardiovascular Division	55
Celsius	Biosense Webster, Inc.	47
Response™	St. Jude Medical Cardiovascular Division	46
Torqr™	Medtronic, Inc.	32
Catheter, Electrode Recording, Or Probe, Electrode Recording	Medtronic, Inc.	27
Lasso NAV	Biosense Webster, Inc.	22

Showing 12 of 112. All products under Catheter, Electrode Recording, Or Probe, Electrode Recording

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233397	2023-12-02
K190132	2019-07-30
K183547	2019-07-30
K162892	2016-11-15
K153139	2016-05-06

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Achieve™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medtronic, Inc.	510(k) number	2015-09-29	Class II	Under Investigation by firm	64 units of Achieve Electrical Cables were shipped with a potential sterility breach.	64 units	2016-03-09

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P950005	2001-10-05	CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	Biosense Webster, Inc.

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.

Achieve™