# K021735: Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Aug 8, 2002 after 72 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001134 (2000). 1 ancestor in all.
165 later devices descend from it; 3 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001134: Gazelle Balloon Dilatation Catheter, Boston Scientific Corp (2000)

## Most influential descendants
- K050389: Ultra-Soft SV Balloon Dilatation Catheter (2005), 164 descendants of its own
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx (2005), 133 descendants of its own
- K072283: Dorado Pta Balloon Dilatation Catheter (2007), 96 descendants of its own
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx (2005), 62 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own

## Recalls of this device
- Jul 1, 2003 · Not classified · Z-1118-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1120-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1110-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1113-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1106-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1112-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1111-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1097-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1096-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1098-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1108-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1119-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1103-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1117-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1100-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1115-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1099-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1114-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1105-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1104-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1101-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1116-03: Some of the product pouches have holes in the seals.
- Jul 1, 2003 · Not classified · Z-1107-03: Some of the product pouches have holes in the seals.

## Indications for use
The Ultra-soft SV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K021735
Methodology: https://510kreport.com/methodology