# K021996: Bolton Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bolton Medical, Inc.
- Decided: Aug 23, 2002 after 66 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: 3 generations back to K920547 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972512: Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel, Boston Scientific Scimed, Inc. (1998) Summary page 1.
- K003972: Numed Ghost II Pta Catheters, NuMED, Inc. (2001) Summary page 1.
- K001087: Pta Balloon Catheter, Cook, Inc. (2000)
- K000101: RX Viatrac 14 Peripheral Dilatation Catheter, Guidant Corp. (2000)
- K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter, Mallinckroot, Inc. (1999) Summary page 1.
- K973013: Opti-Plast (Centurion) 5.5F Angioplasty Catheter, Vas-Cath, Inc. (1998). Our reading of the summary gave K973012, FDA’s number for MDC Safe Step Safety Blood Collection Needle System (MDC Research, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Opti-plast Centurion 5.5 PTA Catheter”.

## Indications for use
The Bolton PTA Catheter is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is not intended for use in the coronary arteries.

Source page: https://510kreport.com/device/K021996
Methodology: https://510kreport.com/methodology