# K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckroot, Inc.
- Decided: Apr 16, 1999 after 168 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920547 (1992). 8 ancestors in all.
12 later devices descend from it; 2 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965183: Vantage Peripheral Dilatation Catheter, Guidant Corp. (1997) Summary page 1.
- K960517: Bard Tru-Trac Peripheral Balloon Dilatation Catheter, C.R. Bard, Inc. (1996) Summary page 1.
- K924320: Ultra Thin Balloon Dilatation Catheter, Boston Scientific Corp (1993) Summary page 1.
- K904984: Advance 418(TM), Peripheral Systems Group (1991) Summary page 1.
- K953602: Symmetry Small Vessel Balloon Dilatation Catheter, Boston Scientific Corp (1995) Summary page 1.
- K924047: Sub-4 Small Vessel Balloon Dilatation Catheter, Boston Scientific Corp (1992) Summary page 1.

## Most influential descendants
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), 10 descendants of its own
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K041044: Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set (2004), 2 descendants of its own

## Indications for use
The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

Source page: https://510kreport.com/device/K983830
Methodology: https://510kreport.com/methodology