Data / Medical devices / Netherlands / Oldelft B.V.

Oldelft B.V.: FDA-registered device maker in Delft Zuid-Holland, Netherlands, 1 510(k) clearance

Name: Oldelft B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Oldelft B.V. is registered with the FDA (registration 1000601180) in Delft Zuid-Holland, Netherlands. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 2, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1000601180
Address: Heertjeslaan 10, Delft Zuid-Holland, Netherlands, 2629 JG
Owner or operator: Oldelft B.V. (10047391)
Roles: Contract manufacturer, Manufacturer
First device listed: August 21, 2014
Registered through: 2026
Brand names listed: 10T-D microMulti TEE Probe, 171V400 miniMulti TEE Probe , supplied by Oldelft to Siemens (Siemens model V7M), S7-3t, S7-3t compact, S8-3t

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Ultrasound, Intravascular	OBJ	2	Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer, Manufacturer	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
November 2, 2017	K173341	Vivid E80, Vivid E90, Vivid E95	IYN	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov

Compare with other makers

Updated November 2, 2017. 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.