Bacchus Vascular, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Bacchus Vascular, Inc. makes
Bacchus Vascular, Inc. manufactures peripheral infusion systems and thrombectomy catheters for vascular procedures. The Trellis and Trellis-Plus infusion systems include catheters with varying lengths (10 cm, 20 cm, 100 cm, and 140 cm) designed for drug delivery or fluid infusion in peripheral vessels. Thrombectomy catheters, such as the Bacchus Thrombectomy Catheter (BTC) and Solera Magnum/Solera Plus models (55 cm and 110 cm), are intended for clot removal in vascular treatments. Additional infusion systems like Trellis-6, Trellis-8, and SpiralFuse cater to peripheral vascular access needs.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) registry. Bacchus Vascular, Inc. is based in the United States.
Catalogue
Trellis Infusion System (10cm Infusion Length); Trellis Infusion System (20cm Infusion Length) Ref K013635
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Trellis Reserve Infusion System Ref K032261
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Trellis-6 Peripheral Infusion System Ref K071664
Regimes: 510(k) Registry: 510(k)Trellis-8 Peripheral Infusion System Ref K050147
Regimes: 510(k) Registry: 510(k)Spiralfuse Peripheral Infusion System Ref K082199
Regimes: 510(k) Registry: 510(k)Solera Plus Thrombectomy Catheter, 55 Cm And 110 Cm, Models Bac Smg 007 055, Bac Smg 007 110 Ref K033997
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Bacchus Vascular, Inc., initiated on 2003-11-24. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 24 Nov 2003 Z-0816-04 Unclassified (pre-2012) Terminated The device has the potential for fractures at the distal end during use.
Full distribution text
- 24 Nov 2003 Z-0817-04 Unclassified (pre-2012) Terminated The device has the potential for fractures at the distal end during use.
Full distribution text
- 24 Nov 2003 Z-0816-04 Unclassified (pre-2012) Terminated The device has the potential for fractures at the distal end during use.
Frequently asked questions
How many devices does Bacchus Vascular, Inc. have in the registry?
The registry currently lists 10 devices for Bacchus Vascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bacchus Vascular, Inc.'s devices?
Among its 10 most recently registered devices, Bacchus Vascular, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Bacchus Vascular, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Bacchus Vascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bacchus Vascular, Inc.?
FDA recall records list 2 recalls initiated by Bacchus Vascular, Inc., the most recent initiated on 24 Nov 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 Bacchus Vascular, Inc. in the registry?
The most recently registered devices listed for Bacchus Vascular, Inc. include TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH), TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH), BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 and Trellis Reserve Infusion System.