Company ยท US
St. Jude Medical / Daig Division
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2005. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2007 | St. Jude Medical / Daig Division FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. Terminated |
DYB | K964518 |
| Nov 7, 2006 | St. Jude Medical / Daig Division The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size. Terminated |
MGB | None listed |
| Jun 3, 2006 | St. Jude Medical / Daig Division St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agil Terminated |
DYB | K042623 |
| Mar 25, 2006 | St. Jude Medical / Daig Division Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA. Terminated |
MGB | None listed |
| Nov 3, 2005 | St. Jude Medical / Daig Division Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Terminated |
DYB | K884494 |
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-r Terminated |
DYB | K964518 K973840 +1 |
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi Terminated |
DYB | K964518 K973840 +1 |