510(k) Report

510(k) · Cleared

Cleared

Boston Scientific/Target Sentry Occlusion Balloon Catheter

K993292510(k) TraditionalCleared Mar 23, 2000174-day reviewClass II21 CFR 870.4450

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

Boston Scientific, Target · MJN Catheter, Intravascular Occluding, Temporary

Cleared on Mar 23, 2000 as substantially equivalent to K921399 (Interventional Therapeutics Corp., 1992) and 6 other predicates after a 174-day review. Its family tree reaches back 1 generation to 1979. 6 later devices descend from it.

Decided
Mar 23, 2000
Review
174 days
Class
Class II
Product code
MJN
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K781772 (1979). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2008: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant clearedK781772 · Catheter, Transluminal Balloon · Medi-Tech, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K781772 · Catheter, Transluminal Balloon · Medi-Tech, Inc. · 19790+5
  1. Root · 1 generation backK781772 Catheter, Transluminal BalloonMedi-Tech, Inc. · 1979
  2. This deviceK993292 Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target · 2000
  3. Descendant · cites it directly · 4 of its ownK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
  4. Descendant · 2 generations on · 3 of its ownK091504 Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit…Micrus Endovascular Corporation · 2009
  5. Descendant · 3 generations on · 2 of its ownK103780 Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent…Micrus Endovascular Corporation · 2011
  6. Descendant · 4 generations on · 1 of its ownK142692 Occlusion Balloon CatheterEmbolx, Inc. · 2015
  7. Descendant · 5 generations on · 0 of its ownK180904 Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12011: 12015: 12018: 1
2008high 2 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008 · cites it directly4descendants
  • K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation · 2009 · 2 generations on3descendants
  • K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation · 2011 · 3 generations on2descendants
  • K142692Occlusion Balloon CatheterEmbolx, Inc. · 2015 · 4 generations on1descendant
  • K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc. · 2018 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K781772Catheter, Transluminal BalloonMedi-Tech, Inc.1979—
0 (this device)K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target2000—
+1K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation2008—
+2K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion…Micrus Endovascular Corporation2009—
+3K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion…Micrus Endovascular Corporation2011—
+4K142692Occlusion Balloon CatheterEmbolx, Inc.2015—
+5K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199410
199510
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201110
201510
201810
FIG. 1 — Lineage of K993292, 1979–2018Source: 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), 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 MJN? 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 MJN device

  1. #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK895445Boston Scientific/Target NDSB
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…n Balloon Catheter II. Name of Predicate Devices Predicate Devices for the Boston Scientific/Target Sentry Occlusion Balloon Catheter: Boston Scientific/Target NDSB® (K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophil…
*K921399Occlusion Ballon Catheter Modificaion
Summary page 1
…Catheter II. Name of Predicate Devices Predicate Devices for the Boston Scientific/Target Sentry Occlusion Balloon Catheter: Boston Scientific/Target NDSB® (K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTra…
Interventional Therapeutics Corp.1992—
*K950398Catheter, Balloon Type
Summary page 1
…r II. Name of Predicate Devices Predicate Devices for the Boston Scientific/Target Sentry Occlusion Balloon Catheter: Boston Scientific/Target NDSB® (K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infu…
Interventional Therapeutics Corp.1995—
*K960832Occlusion Balloon Catheter
Summary page 1
…me of Predicate Devices Predicate Devices for the Boston Scientific/Target Sentry Occlusion Balloon Catheter: Boston Scientific/Target NDSB® (K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infusion Cath…
Interventional Therapeutics Corp.1996—
*K781772Catheter, Transluminal Balloon
Summary page 1
…c/Target Sentry Occlusion Balloon Catheter: Boston Scientific/Target NDSB® (K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infusion Catheter (K926243, K925813) Boston Scientific/Target TurboTracker Inf…
Medi-Tech, Inc.1979—
*K926243Angiographic Catheter
Summary page 1
…K895445, K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infusion Catheter (K926243, K925813) Boston Scientific/Target TurboTracker Infusion Catheter (K960806) ITII. Device Description The Sentry Occlusion Ball…
Target Therapeutics1993—
*K925813Diagnostic Intravascular Catheter
Summary page 1
…K921399, K950398, K960832) Boston Scientific/Medi-tech Occlusion Balloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infusion Catheter (K926243, K925813) Boston Scientific/Target TurboTracker Infusion Catheter (K960806) ITII. Device Description The Sentry Occlusion Balloon Cathe…
Target Therapeutics1994—
*K960806Turbo Tracker
Summary page 1
…alloon Catheter (K781772) Boston Scientific/Target Hydrophilic FasTracker Infusion Catheter (K926243, K925813) Boston Scientific/Target TurboTracker Infusion Catheter (K960806) ITII. Device Description The Sentry Occlusion Balloon Catheter consists of an over-the-wire catheter with a soft compliant bal…
Target Therapeutics1996—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084
K070126Occlusion Balloon CatheterSentreheart, Inc.20080

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K080861 (Micrus Endovascular Corporation, 2008) has gone furthest, with 4 descendants of its own.

How does its category compare?

All MJN devices

MJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJN

2in 2025

2007: 22008: 32009: 52010: 52011: 42012: 22013: 42014: 22015: 42016: 32017: 32018: 32019: 32020: 42021: 42022: 22023: 12025: 2
2007high 5 (2009) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJN

116in 2021

2008: 153 days median2009: 39 days median2010: 30 days median2011: 69 days median2013: 87 days median2015: 245 days median2016: 110 days median2017: 54 days median2018: 63 days median2019: 117 days median2020: 64 days median2021: 116 days median
2007high 245 (2015) · low 30 (2010)2026

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

Recalls per year · MJN

1in 2020

2008: 22010: 12011: 12013: 82015: 12016: 22018: 12020: 1
2007high 8 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJN

194in 2025

2007: 252008: 262009: 252010: 352011: 922012: 532013: 762014: 1002015: 902016: 712017: 1572018: 1072019: 1392020: 1572021: 1582022: 1482023: 1812024: 2242025: 194
2007high 224 (2024) · low 25 (2007)2025

MAUDE reports naming product code MJN, 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
20072—025
20083153226
2009539025
2010530135
2011469192
20122—053
2013487876
20142—0100
20154245190
20163110271
20173540157
20183631107
201931170139
20204641157
202141160158
20222—0148
20231—0181
20240—0224
20252—0194
20260—0—

What is it indicated for?

The Boston Scientific/Target Sentry Occlusion Balloon Catheter is intended for temporary intravascular occlusion. This device is not intended for use in coronary arteries. This device is not intended for use in the neurovasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Boston Scientific, Target

19 FDA decisions under this applicant name. See the company

  • K031049Guglielmi Detachable Coil (GDC)Boston Scientific, Target · 2003
  • K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 200310 recalls
  • K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target · 20031 recall
  • K022860Atlantis PV Imaging Catheter, Model 36456Boston Scientific, Target · 2002
  • K022357Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815Boston Scientific, Target · 2002

Recent decisions in MJN

The MJN category page

  • K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025
  • K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices · 2025
  • K221294preCARDIA Occlusion SystemAbiomed, Inc. · 2023
  • K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc. · 2022
  • K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2022

https://510kreport.com/device/K993292 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993292: Boston Scientific/Target Sentry Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993292

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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