Vital Concepts, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA recalls
What Vital Concepts, Inc. makes
Vital Concepts, Inc. makes irrigation sets, suction/irrigation tubing sets, and insuflator filters with tubing for medical use.
The company's devices are classified as Class II and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Irrigation Sets Ref K032832
Regimes: 510(k) Registry: 510(k)Vci Insuflator Filter W/ Tubing Ref K930192
Regimes: 510(k) Registry: 510(k)Vci Suction/Irrigation Tubing Set Ref K934382
Regimes: 510(k) Registry: 510(k)Vitaflow Suction/Aspiration Tubing Set Ref K960616
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 10 recalls initiated by Vital Concepts, Inc., the earliest on 2003-07-11 and the most recent on 2003-11-07. By recorded status: 10 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
- 7 Nov 2003 Z-0258-04 Unclassified (pre-2012) Terminated The probe may separate from the cannula.
- 7 Nov 2003 Z-0259-04 Unclassified (pre-2012) Terminated The probe may separate from the cannula.
- 7 Nov 2003 Z-0260-04 Unclassified (pre-2012) Terminated The probe may separate from the cannula.
- 7 Nov 2003 Z-0261-04 Unclassified (pre-2012) Terminated The probe may separate from the cannula.
- 11 Jul 2003 Z-0020-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
- 11 Jul 2003 Z-0021-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
- 11 Jul 2003 Z-0022-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
- 11 Jul 2003 Z-0023-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
- 11 Jul 2003 Z-0024-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
- 11 Jul 2003 Z-0025-04 Unclassified (pre-2012) Terminated The suction valve may become stuck in the 'suction on' position under vacuum.
Full distribution text
Frequently asked questions
How many devices does Vital Concepts, Inc. have in the registry?
The registry currently lists 4 devices for Vital Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vital Concepts, Inc.'s devices?
Among its 4 most recently registered devices, Vital Concepts, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Vital Concepts, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Vital Concepts, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vital Concepts, Inc.?
FDA recall records list 10 recalls initiated by Vital Concepts, Inc., the most recent initiated on 7 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 Vital Concepts, Inc. in the registry?
The most recently registered devices listed for Vital Concepts, Inc. include IRRIGATION SETS, VCI INSUFLATOR FILTER W/ TUBING, VCI SUCTION/IRRIGATION TUBING SET and VITAFLOW SUCTION/ASPIRATION TUBING SET.