# K122937: Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix)

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 14, 2012 after 81 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882796 (1988). 1 ancestor in all.
9 later devices descend from it; 8 cite it directly.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882796: Slip-Coat (TM) Catheters, Cook, Inc. (1988) Summary page 1.

## Most influential descendants
- K162448: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (2017), 1 descendant of its own
- K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter (2015), 1 descendant of its own
- K181722: Polyethylene Catheter (2019), 0 descendants of its own
- K180286: Polyethylene Catheter (2018), 0 descendants of its own
- K180054: Royal Flush Plus High-Flow Catheter (2018), 0 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-2614-2016: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading t
- Apr 15, 2016 · Class II · Z-2613-2016: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading t
- Oct 7, 2015 · Class I · Z-0798-2016: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end
- Jul 2, 2015 · Class I · Z-2319-2015: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end

## Indications for use
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Source page: https://510kreport.com/device/K122937
Methodology: https://510kreport.com/methodology