510(k) K021735 ยท DQY Catheter, Percutaneous
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 8, 2002 |
| Received | May 28, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-6520 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-7020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-5015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6515 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015
, Product Number H7493791540150 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-6020 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020 Terminated |
GBR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.