R4 Vascular, Inc.
St. Paul, MN, US
R4 Vascular, Inc. appears in FDA device records in St. Paul, MN. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for R4 Vascular, Inc. between 2007 and 2013. The busiest year on record is 2009, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131329 | VECTOR PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K121385 | VECTOR | LIT | Substantially Equivalent | |
| K100169 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER | MSD | Unknown | |
| K091506 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 | MSD | Unknown | |
| K092040 | PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 | LJS | Substantially Equivalent | |
| K083763 | ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN | LJS | Substantially Equivalent | |
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 | LJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2412-2011 | DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing. | 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 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain