TRELLIS-6 PERIPHERAL INFUSION SYSTEM— 510(k) K071664
Substantially EquivalentBacchus Vascular, Inc.
FDA 510(k) clearance K071664 for TRELLIS-6 PERIPHERAL INFUSION SYSTEM, Substantially Equivalent on 2007-07-13. Applicant: Bacchus Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bacchus Vascular, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
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- K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
- K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
More clearances from Bacchus Vascular, Inc.
view all- K082199 — SPIRALFUSE PERIPHERAL INFUSION SYSTEM
- K050147 — TRELLIS-8 PERIPHERAL INFUSION SYSTEM
- K033997 — SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
- K032261 — Trellis Reserve Infusion System
- K022640 — SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
Recalls naming K071664
K-number listed on FDA's recall record- Z-1365-2015 — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
- Z-1017-2015 — Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071664.
Data sourced from openFDA. This site is unofficial and independent of the FDA.