510(k) Report

FDA applicant

Bacchus Vascular, Inc.

Santa Clara, CA10 decisions2001–20084 recalls

FDA records 10 decisions for Bacchus Vascular, Inc. (Santa Clara, CA) from 2001 to 2008: 10 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and MCW (Catheter, Peripheral, Atherectomy). Its devices cite 14 predicates, 10 of them its own earlier devices. 4 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Bacchus Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2014: 1, 1 Class I2015: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bacchus Vascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bacchus Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QEYMechanical Thrombolysis Catheter7decisions
  • MCWCatheter, Peripheral, Atherectomy3decisions

Whose devices does it build on?

Its devices cite 14 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length)Bacchus Vascular, Inc. · 20025cite it
  • K003570Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Bacchus Vascular, Inc. · 20014cite it
  • K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 20053cite it
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 20022cite it
  • K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc. · 20031cites it
  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 20071cites it

What has FDA decided for it lately?

  • K082199Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc. · 2008
  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 20071 Class I recall
  • K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc. · 2005
  • K033997Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007 110Bacchus Vascular, Inc. · 2004
  • K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc. · 2003
  • K022640Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum Thrombectomy Catheter, 110…Bacchus Vascular, Inc. · 2002
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 20021 recall
  • K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM…Bacchus Vascular, Inc. · 20021 recall

All 10 as Bacchus Vascular, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K071664Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only.…Mar 23, 2015Class II
  • K071664Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01…Dec 10, 2014Class I
  • K021958Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR…Nov 24, 2003
  • K023514Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC…Nov 24, 2003