510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

MAMBA and MAMBA Flex Microcatheters

K190401510(k) SpecialCleared Mar 15, 201924-day reviewClass II21 CFR 870.1250Recalls 2

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

Boston Scientific Corporation · DQY Catheter, Percutaneous

Cleared on Mar 15, 2019 as substantially equivalent to K171452 (Boston Scientific Corporation, 2017) after a 24-day review. Its family tree reaches back 1 generation to 2017. It has been recalled 2 times.

Decided
Mar 15, 2019
Review
24 days
Class
Class II
Product code
DQY
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K171452 (2017). No later device cites it as a predicate yet.

Reference device: K171612 · ACUITY Pro Lead Delivery System · Boston Scientific Corporation · 2017K171452 · MAMBA and MAMBA FLEX Microcatheters · Boston Scientific Corporation · 2017201620182020
K171452 · MAMBA and MAMBA FLEX Microcatheters · Boston Scientific Corporation · 20170
  1. Root · 1 generation backK171452 MAMBA and MAMBA FLEX MicrocathetersBoston Scientific Corporation · 2017
  2. This deviceK190401 MAMBA and MAMBA Flex MicrocathetersBoston Scientific Corporation · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K171452MAMBA and MAMBA FLEX MicrocathetersBoston Scientific Corporation2017—
0 (this device)K190401MAMBA and MAMBA Flex MicrocathetersBoston Scientific Corporation2019—
FIG. 1 — Lineage of K190401, 2017–2019Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K171452MAMBA and MAMBA FLEX Microcatheters
Summary page 4
…DQY Classification Class II, 21 CFR Part 870.1250 MAMBA™ and MAMBA™ Flex Predicate Device Microcatheters K171452 (21 Aug 2017) Acuity Pro Guide catheter Reference Device K171612 (30 Jun 2017) === Page 5…
Boston Scientific Corporation2017—
†K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation2017—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 5, 2021Class IIZ-1429-2021Labeling False and MisleadingThe firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Mar 5, 2021Class IIZ-1430-2021Labeling False and MisleadingThe firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The MAMBA and MAMBA Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another.

The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

Indications for use as stated in the FDA summary.

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The DQY category page

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https://510kreport.com/device/K190401 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190401: MAMBA and MAMBA Flex Microcatheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190401

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026