Vasca, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Vasca, Inc. makes
Vasca, Inc. manufactures components for hemodialysis access systems, including cannula exchange kits, insertion kits, and access cannulas designed for vascular access in patients undergoing hemodialysis.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Lifesite Hemodialysis Access System, Cannula Exchange Kit, Insertion Kit, Access Cannila Ref K023023
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Vasca, Inc., initiated on 2003-09-22. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 22 Sep 2003 Z-0045-04 Unclassified (pre-2012) Terminated Outer kit mislabeled with an extended expiration date
Frequently asked questions
How many devices does Vasca, Inc. have in the registry?
The registry currently lists 2 devices for Vasca, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vasca, Inc.'s devices?
Among its 2 most recently registered devices, Vasca, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Vasca, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Vasca, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vasca, Inc.?
FDA recall records list 1 recall initiated by Vasca, Inc., the most recent initiated on 22 Sep 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 Vasca, Inc. in the registry?
The most recently registered devices listed for Vasca, Inc. include LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA and LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000.