Who else makes this device?

Name: Delta®
Brand: Delta®

Delta® · Device, Monitoring, Intracranial Pressure → Neurology

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWM
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33

Record

Regulatory record for Delta®
Listed by	Medtronic PS Medical, United States
FDA product code	GWM
Device type	Device, Monitoring, Intracranial Pressure
Device class	Class 2
Regulation	21 CFR 882.1620
510(k)	K984053
Record published	2015-07-08
Record revised	2022-10-10 (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
Sizes	Length 130 mm

Catalogue Numbers

Catalogue numbers for Delta®
Catalogue number	Size	Status
276411	Performance Level 1.0	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Licox®	GMS, Gesellschaft für medizinische Sondentechnik mbH	38
Sophysa	Sophysa	32
Becker®	Medtronic PS Medical	31
Codman	Cerenovus, Inc.	29
Device, Monitoring, Intracranial Pressure	Medtronic PS Medical	28
Exacta™	Medtronic PS Medical	28
Braincare	Braincare Desenvolvimento E Inovacao Tecnologica SA	24
Camino®	Integra Lifesciences (Ireland) Limited	20
Codman®	Integra LifeSciences Production Corporation	19
Integra®	Integra Lifesciences (Ireland) Limited	17
Aura	Branchpoint & Aura Development LLC	17
Natus	Natus Medical Incorporated	15

Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K983799	1999-01-26

Recalls Naming This Product

6 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Delta®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medtronic Neurosurgery	510(k) number	2023-06-28	Class II	Labeling Change Control	Product labeling contains incorrect expiration date	44 units
Medtronic Neurosurgery	510(k) number	2014-06-09	Class I	Device Design	Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.	3,026 units	2015-01-14
Medtronic Neurosurgery	510(k) number	2014-06-09	Class I	Device Design	Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.	5,744 units	2015-01-14
Medtronic Neurosurgery	510(k) number	2014-06-09	Class I	Device Design	Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.	760 units	2015-01-14
Medtronic Neurosurgery	510(k) number	2014-06-09	Class I	Device Design	Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.	1,187 units	2015-01-14
Medtronic Neurosurgery	510(k) number	2014-06-09	Class I	Device Design	Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.	35 units	2015-01-14

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.

Delta®