510(k) K063618 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
TENDERFLOW PERIATRIC ARTERIAL CANNULA
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Mar 13, 2007 |
| Received | Dec 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568.
The TenderFlow (TM) Pediatric Arterial Cannula is indicat Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.
The TenderFlow (TM) Pediatric Arterial Cannula is indicat Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573.
The TenderFlow (TM) Pediatric Arterial Cannula is indicate Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575.
The TenderFlow (TM) Pediatric Arterial Cannula is indicated Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577.
The TenderFlow (TM) Pediatric Arterial Cannula is indicate Terminated |
DWF | None listed |
| Feb 6, 2009 | Terumo Cardiovascular Systems Corporation Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.
The TenderFlow (TM) Pediatric Arterial Cannula is indic Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577. Terminated |
DWF | None listed |
| Jul 10, 2007 | Terumo Cardiovascular Systems Corp Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.