R4 Vascular, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What R4 Vascular, Inc. makes
R4 Vascular, Inc. manufactures hemodialysis catheters, including long-term models like the DURASPAN, and peripheral intravenous catheters such as the PEGASUS CT PICC and ZEUS CT PICC (single and dual lumen). The company also produces angioplasty tools, including the VECTOR PTA balloon dilatation catheter, and high-flow vascular access devices like the Pherocious 10.5 Fr catheter.
The company’s products are classified under FDA Class II devices and are listed via 510(k) clearance in the United States. All devices are regulated under US FDA jurisdiction, with no additional international registries specified.
Catalogue
Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 Ref K091506
510(k) 510(k)Vector Ref K121385
510(k) 510(k)Vector Pta Balloon Dilatation Catheter Ref K131329
510(k) 510(k)Duraspan Hemodialysis Long-Term Catheter Ref K100169
510(k) 510(k)R4 Vascular Inc. Pegasus Ct Picc, Model 500005-001, 002, 004, 005, 500004-001, 002, 004, 005 Ref K071361
510(k) 510(k)- 510(k) 510(k)
Zeus Ct Picc 4 Fr And 5 Fr Single And Dual Lumen Ref K083763
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by R4 Vascular, Inc., initiated on 2011-05-03. By recorded status: 1 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.
2011
- 3 May 2011 Z-2412-2011 Unclassified (pre-2012) Terminated r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lot
Frequently asked questions
How many devices does R4 Vascular, Inc. have in the registry?
The registry currently lists 7 devices for R4 Vascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list R4 Vascular, Inc.'s devices?
Among its 7 most recently registered devices, R4 Vascular, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do R4 Vascular, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for R4 Vascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for R4 Vascular, Inc.?
FDA recall records list 1 recall initiated by R4 Vascular, Inc., the most recent initiated on 2011-05-03. 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 R4 Vascular, Inc. in the registry?
The most recently registered devices listed for R4 Vascular, Inc. include DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520, VECTOR, VECTOR PTA BALLOON DILATATION CATHETER and DURASPAN HEMODIALYSIS LONG-TERM CATHETER.