Bacchus Vascular, Inc.
Santa Clara, CA, US
Bacchus Vascular, Inc. appears in FDA device records in Santa Clara, CA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Bacchus Vascular, Inc. between 2001 and 2008. The busiest year on record is 2002, with 4. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082199 | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K050147 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K033997 | SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 | MCW | Substantially Equivalent | |
| K032261 | Trellis Reserve Infusion System | QEY | Substantially Equivalent | |
| K023514 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) | QEY | Substantially Equivalent | |
| K022640 | SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM | MCW | Substantially Equivalent | |
| K021958 | TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H | QEY | Substantially Equivalent | |
| K013635 | TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) | QEY | Substantially Equivalent | |
| K003570 | BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 | MCW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0817-04 | Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRE 06 100 10, BAC TRE 06 100 20, BAC TRE 06 140 10, BAC TRE 06 140 20 | The device has the potential for fractures at the distal end during use. | Terminated | ||
| Z-0816-04 | Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20 | The device has the potential for fractures at the distal end during use. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain