SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110— 510(k) K033997
Substantially EquivalentBacchus Vascular, Inc.
FDA 510(k) clearance K033997 for SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110, Substantially Equivalent on 2004-02-04. Applicant: Bacchus Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bacchus Vascular, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code MCW
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view all- K082199 — SPIRALFUSE PERIPHERAL INFUSION SYSTEM
- K071664 — TRELLIS-6 PERIPHERAL INFUSION SYSTEM
- K050147 — TRELLIS-8 PERIPHERAL INFUSION SYSTEM
- K032261 — Trellis Reserve Infusion System
- K022640 — SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.