Data / Medical devices / United States / Confluent Medical Technologies, Inc
Confluent Medical Technologies, Inc: FDA-registered device maker in Fremont, CA, United States, 1 510(k) clearance
Confluent Medical Technologies, Inc is registered with the FDA (registration 3007635982) in Fremont, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 28, 2001. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007635982
- Address
- 47533 Westinghouse Dr, Fremont, CA, United States, 94539
- Owner or operator
- Confluent Medical Technologies, Inc. (10033958)
- Roles
- Specification developer
- First device listed
- October 21, 2010
- Registered through
- 2027
- Brand names listed
- Aquatrack Hydrophilic Nitinol Guidewire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2001 | K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES | DQX | Substantially Equivalent | Maxxim Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 28, 2014 | 68419 | Class I | Terminated | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. | accessdata.fda.gov |
Compare with other makers
Updated June 25, 2014. 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.