Data / Medical devices / Probe, Blood-Flow, Extravascular
Probe, Blood-Flow, Extravascular (DPT): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make Probe, Blood-Flow, Extravascular (product code DPT, Class 2, 21 CFR 870.2120). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on May 28, 2024, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DPT
- Device class
- 2
- Regulation
- 870.2120
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| Mexico | 2 |
| China | 2 |
| Norway | 2 |
| Sweden | 1 |
| Taiwan | 1 |
Makers of Probe, Blood-Flow, Extravascular
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Moor Instruments Ltd. | AXMINSTER Devon, United Kingdom | Complaint file establishment, Manufacturer | 6 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Deltex Medical Limited | CHICHESTER West Sussex, United Kingdom | Manufacturer | 3 | January 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 3 | May 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 3 | May 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | August 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | August 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | August 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Perimed AB | JARFALLA Stockholm, Sweden | Complaint file establishment, Manufacturer | 1 | July 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| RWD Life Science Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | May 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medistim Asa | HORTEN Vestfold, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medistim Asa | Oslo, Norway | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 28, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.