Venetec, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Venetec, Inc. makes
Venetec, Inc. manufactures STATLOCK security devices, including the STATLOCK-IPIDURAL for securing intravenous lines and catheters, STATLOCK CV for central venous access, STATLOCK IV connector and anchor sets, and STATLOCK general securement devices to prevent dislodgement or tampering.
These products are regulated under FDA Class I and Class II classifications, with relevant devices authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Statlock-Ipidural Ref K943038
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Statlock Securement Devices Ref K942931
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Statlock Cv Ref K943147
Regimes: 510(k) Registry: 510(k)Statlock Iv Connector And Anchor Set Ref K902109
Regimes: 510(k) Registry: 510(k)
FDA recalls
2003
- 12 May 2003 Z-0925-03 Unclassified (pre-2012) Terminated Set tubing disconnected from the male luer lock during use on patients. Misassembled.
Frequently asked questions
How many devices does Venetec, Inc. have in the registry?
The registry currently lists 6 devices for Venetec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Venetec, Inc.'s devices?
Among its 6 most recently registered devices, Venetec, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Venetec, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Venetec, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Venetec, Inc.?
FDA recall records list 1 recall initiated by Venetec, Inc., the most recent initiated on 12 May 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Venetec, Inc. in the registry?
The most recently registered devices listed for Venetec, Inc. include STATLOCK-IPIDURAL, IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES, STATLOCK SECUREMENT DEVICES and IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES.