510(k) K093392 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Dec 31, 2009 |
| Received | Oct 30, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K093392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Navilyst Medical, Inc Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- M Terminated |
FGE | None listed |
| Jan 11, 2012 | Navilyst Medical, Inc Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 eaches --- Terminated |
FGE | None listed |
| Oct 7, 2010 | Navilyst Medical, Inc Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centenn Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.