510(k) Report

510(k) · Cleared

Recalled · 2008

6F Mach 1, Model 34356-XXX

K010874510(k) TraditionalCleared Jun 21, 200190-day reviewClass II21 CFR 870.1250Recalls 11

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

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on Jun 21, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 160 later devices descend from it. It has been recalled 11 times.

Decided
Jun 21, 2001
Review
90 days
Class
Class II
Product code
DQY
Recalls
11
Predicates
0

160 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2003: 1 descendant cleared2002: 1 descendant cleared2010: 5 descendants cleared2007: 2 descendants cleared2004: 1 descendant cleared2009: 2 descendants cleared2013: 6 descendants cleared2012: 9 descendants cleared2015: 8 descendants cleared2011: 6 descendants cleared2014: 8 descendants cleared2016: 11 descendants cleared2017: 13 descendants cleared2021: 5 descendants cleared2018: 10 descendants cleared2020: 8 descendants cleared2023: 14 descendants cleared2022: 12 descendants cleared2019: 7 descendants cleared2025: 14 descendants cleared2026: 8 descendants cleared2024: 8 descendants cleared200020052010201520202025
  1. This deviceK010874 6F Mach 1, Model 34356-XXXBoston Scientific Corp · 2001
  2. Descendant · cites it directly · 132 of its ownK020028 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F…Boston Scientific · 2002 · Recalled
  3. Descendant · cites it directly · 109 of its ownK061601 Asahi Precious Guide CatheterAsahi Intecc Co., Ltd. · 2006
  4. Descendant · 2 generations on · 105 of its ownK093268 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · Recalled
  5. Descendant · 3 generations on · 103 of its ownK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
  6. Descendant · 3 generations on · 90 of its ownK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled

Showing 5 of 160 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12006: 12007: 22009: 22010: 52011: 62012: 92013: 62014: 82015: 82016: 112017: 132018: 102019: 72020: 82021: 52022: 122023: 142024: 82025: 142026: 8
2002high 14 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 160 · See all
  • K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXBoston Scientific · 2002 · cites it directly132descendants
  • K061601Asahi Precious Guide CatheterAsahi Intecc Co., Ltd. · 2006 · cites it directly109descendants
  • K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on105descendants
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH · 2010 · 3 generations on103descendants
  • K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0108746F Mach 1, Model 34356-XXXBoston Scientific Corp2001—
+1K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXBoston Scientific200211
+1K061601Asahi Precious Guide CatheterAsahi Intecc Co., Ltd.2006—
+2K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20102
+3K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizin Systeme Boblingen GmbH2010—
+3K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200610
200720
200920
201050
201160
201290
201360
201480
201580
2016110
2017130
2018100
201970
202080
202150
2022120
2023140
202480
2025140
202680
FIG. 1 — Lineage of K010874, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
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? (160)

See all 160

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

NumberDeviceApplicantDecidedDescendants
K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXBoston Scientific2002132
K061601Asahi Precious Guide CatheterAsahi Intecc Co., Ltd.2006109
K033441Boston Scientific 6F Runway Guide CatheterBoston Scientific Corp200326

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 7, 2008Not classifiedZ-1301-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Feb 7, 2008Not classifiedZ-1305-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Feb 7, 2008Not classifiedZ-1304-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Feb 7, 2008Not classifiedZ-1303-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Feb 7, 2008Not classifiedZ-1300-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Feb 7, 2008Not classifiedZ-1302-2008Labeling mix-upsMislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Dec 13, 2006Not classifiedZ-0383-2007OtherExcess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin…
Dec 13, 2006Not classifiedZ-0382-2007OtherExcess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin…
Dec 13, 2006Not classifiedZ-0388-2007OtherExcess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin…
May 24, 2004Not classifiedZ-0432-06OtherSome Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a…
May 24, 2004Not classifiedZ-0433-06OtherSome Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a…

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020028 (Boston Scientific, 2002) has gone furthest, with 132 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

More from Boston Scientific Corp

4,014 FDA decisions under this applicant name. See the company

  • P900056/S229ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P900056/S226ROTAPRO™ Rotational Atherectomy SystemsBoston Scientific Corp · 2026
  • P900056/S228ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P150031/S100Vercise DBS SystemsBoston Scientific Corp · 2026
  • N970003/S311ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2…Boston Scientific Corp · 2026

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K010874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010874: 6F Mach 1, Model 34356-XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010874

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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