510(k) Report

510(k) · Cleared

Cleared

Bacchus Thrombectomy Catheter (BTC), Model BTC-0755

K003570510(k) TraditionalCleared Jun 6, 2001198-day reviewClass II21 CFR 870.4875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bacchus Vascular, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Jun 6, 2001 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.

Decided
Jun 6, 2001
Review
198 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
0

23 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2002: 1 descendant cleared2004: 3 descendants cleared2012: 2 descendants cleared2006: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared2023: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003570 Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Bacchus Vascular, Inc. · 2001
  2. Descendant · cites it directly · 13 of its ownK031610 Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 2003 · Recalled
  3. Descendant · 2 generations on · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
  4. Descendant · 2 generations on · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
  5. Descendant · 2 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
  6. Descendant · 3 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 32006: 22007: 12010: 12012: 22014: 22016: 12017: 12020: 12022: 12023: 22024: 12025: 12026: 1
2002high 3 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 23 · See all
  • K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 2003 · cites it directly13descendants
  • K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · 2 generations on12descendants
  • K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · 2 generations on11descendants
  • K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 2 generations on10descendants
  • K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003570Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Bacchus Vascular, Inc.2001—
+1K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical20031
+2K033793Cleaner II Rotational Thrombectomy SystemRex Medical2003—
+2K040252Cleaner Rotational Thrombectomy System KitRex Medical2004—
+2K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.2006—
+3K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200430
200620
200710
201010
201220
201420
201610
201710
202010
202210
202320
202410
202510
202610
FIG. 1 — Lineage of K003570, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MCW device

  1. #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (23)

See all 23

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical200313
K021096X-Sizer Catheter SystemEv3 Corporation20046
K022640Solera Magnum Thrombectomy Catheter, 55 CM, Model Bac SMG 007 055 & Solera Magnum…Bacchus Vascular, Inc.20021
K033997Solera Plus Thrombectomy Catheter, 55 CM and 110 CM, Models Bac SMG 007 055, Bac SMG 007…Bacchus Vascular, Inc.20040

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K031610 (Rex Medical, 2003) has gone furthest, with 13 descendants of its own.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCW

3in 2025

2007: 52008: 62009: 82010: 62011: 62012: 52013: 52014: 72015: 62016: 52017: 72018: 82019: 32020: 22021: 62022: 62023: 42024: 32025: 32026 (partial year): 1
2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007: 43 days median2008: 33 days median2009: 27 days median2010: 30 days median2011: 39 days median2012: 29 days median2013: 30 days median2014: 117 days median2015: 30 days median2016: 60 days median2017: 91 days median2018: 103 days median2019: 112 days median2021: 119 days median2022: 69 days median2023: 104 days median2024: 41 days median2025: 46 days median
2007high 119 (2021) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MCW

2in 2024

2007: 22008: 12009: 32010: 12016: 22017: 22021: 2, 2 Class I2022: 2, 2 Class I2023: 12024: 2
2007high 3 (2009) · low 0 (2011)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MCW

677in 2025

2007: 502008: 1152009: 1052010: 1672011: 2042012: 1942013: 1342014: 2102015: 3772016: 4092017: 4152018: 5372019: 6182020: 6312021: 7342022: 5662023: 5742024: 6772025: 677
2007high 734 (2021) · low 50 (2007)2025

MAUDE reports naming product code MCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007543250
20086331115
20098273105
20106301167
20116390204
20125290194
20135300134
201471170210
20156300377
20165602409
20177912415
201881030537
201931120618
20202—0631
202161192 (2)734
20226692 (2)566
202341041574
20243412677
20253460677
20261—0—

More from Bacchus Vascular, Inc.

10 FDA decisions under this applicant name. See the company

  • 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

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The MCW category page

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https://510kreport.com/device/K003570 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003570: Bacchus Thrombectomy Catheter (BTC), Model BTC-0755.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003570

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026