# K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Apr 10, 2001 after 127 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 9 cite it directly.
5 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012130: Attain LDS 6216 Left-Heart Delivery System (2001), 97 descendants of its own
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own

## Recalls of this device
- Oct 7, 2011 · Not classified · Z-0168-2012: Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.
- Dec 16, 2010 · Not classified · Z-1225-2011: Compromised sterility/weak or open seals.
- Dec 16, 2010 · Not classified · Z-1228-2011: Compromised sterility/weak or open seals.
- Dec 16, 2010 · Not classified · Z-1227-2011: Compromised sterility/weak or open seals.
- Dec 17, 2009 · Not classified · Z-0661-2010: Radiopaque sheath tip may fracture
- Sep 12, 2008 · Not classified · Z-0131-2009: Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.

Source page: https://510kreport.com/device/K003731
Methodology: https://510kreport.com/methodology