Device, Monitoring, Intracranial Pressure
Catheter 27842 Edms Ventricular STD 28CM
5manufacturers in China registered for this device type
28catalogue numbers in this listing
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.
| 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
| 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 | 2020-04-20 |
| Record revised | 2024-12-23 (version 5) |
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 | Storage environment temperature 10 to 30 °C; Special storage condition: Keep Dry |
| Packaging | Pack of 5 |
| Distribution end date | 2026-04-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 46422 | In distribution | ||
| 25030 | In distribution | ||
| 27303 | In distribution | ||
| 46441 | 5 | In distribution | |
| 27613 | In distribution | ||
| 46440 | 5 | In distribution | |
| 23014 | In distribution | ||
| 27304 | In distribution | ||
| 46442 | 5 | In distribution | |
| 46135 | In distribution | ||
| 46441 | 5 | In distribution | |
| 46441 | 5 | In distribution | |
| 26057 | In distribution | ||
| 20034 | In distribution | ||
| 26020 | In distribution | ||
| 46118 | In distribution | ||
| 27303 | In distribution | ||
| 46137 | In distribution | ||
| 27613 | In distribution | ||
| 46430 | 10 | In distribution | |
| 26020 | In distribution | ||
| 27842 | In distribution | ||
| 27384 | In distribution | ||
| 9041 | In distribution | ||
| 27703 | In distribution | ||
| 27703 | In distribution | ||
| 46141 | Withdrawn | ||
| 46422 | Withdrawn |
Same 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 |
| 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 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983799 | 1999-01-26 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| 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 | 2021-01-11 | Class II | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus | 20,817 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.