510(k) Report

510(k) · Cleared

Cleared

Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter

K973298510(k) TraditionalCleared Jun 26, 1998297-day reviewClass II21 CFR 870.1250

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

Cardima, Inc. · DQY Catheter, Percutaneous

Cleared on Jun 26, 1998 after a 297-day review. The FDA summary names its predicate without a number. 60 later devices descend from it.

Decided
Jun 26, 1998
Review
297 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

60 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2001: 1 descendant cleared2002: 3 descendants cleared2012: 6 descendants cleared2009: 2 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2003: 1 descendant cleared2006: 4 descendants cleared2010: 4 descendants cleared2011: 4 descendants cleared2014: 3 descendants cleared2020: 3 descendants cleared2015: 2 descendants cleared2016: 4 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2023: 3 descendants cleared2017: 3 descendants cleared2018: 1 descendant cleared2026: 2 descendants cleared2025: 4 descendants cleared2022: 1 descendant clearedReference device: K945963 · The Omniguide Guiding Catheter with Balloon · Micro Interventional Systems, Inc. · 19951995200020052010201520202025
  1. This deviceK973298 Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterCardima, Inc. · 1998
  2. Descendant · cites it directly · 26 of its ownK021284 Easytrak Guiding CatheterGuidant Corp. · 2002 · Recalled
  3. Descendant · cites it directly · 25 of its ownK041151 Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004
  4. Descendant · 2 generations on · 25 of its ownK021455 Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F…Guidant Corp. · 2002 · Recalled
  5. Descendant · 2 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
  6. Descendant · 3 generations on · 21 of its ownK031505 Rapido Cut-Away Guiding CatheterGuidant Corporation · 2003 · Recalled

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2001: 12002: 32003: 12004: 32005: 12006: 42007: 12008: 12009: 22010: 42011: 42012: 62013: 12014: 32015: 22016: 42017: 32018: 12019: 22020: 32022: 12023: 32025: 42026: 2
2001high 6 (2012) · low 0 (2021)2026

Most influential descendants

Showing 5 of 60 · See all
  • K021284Easytrak Guiding CatheterGuidant Corp. · 2002 · cites it directly26descendants
  • K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc. · 2004 · cites it directly25descendants
  • K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…Guidant Corp. · 2002 · 2 generations on25descendants
  • K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 2 generations on24descendants
  • K031505Rapido Cut-Away Guiding CatheterGuidant Corporation · 2003 · 3 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973298Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterCardima, Inc.1998—
+1K021284Easytrak Guiding CatheterGuidant Corp.200217
+1K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.2004—
+2K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model#…Guidant Corp.200218
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical20091
+3K031505Rapido Cut-Away Guiding CatheterGuidant Corporation20031

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200230
200310
200430
200510
200640
200710
200810
200920
201040
201140
201260
201310
201430
201520
201640
201730
201810
201920
202030
202210
202330
202540
202620
FIG. 1 — Lineage of K973298, 1998–2026Source: 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), 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
Get a 510(k) Report

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
*—Electro-Catheter Corp., Elecath Occlusion Catheter
Named without a submission number
—
†K945963The Omniguide Guiding Catheter with BalloonMicro Interventional Systems, Inc.1995—

What descends from it? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K021284Easytrak Guiding CatheterGuidant Corp.200226
K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.200425
K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043
K012225Attain 6215 Venogram Balloon CatheterMedtronic Vascular20011
K021283Guidant Balloon Catheter, Several ModelsGuidant Corp.20020

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, K021284 (Guidant Corp., 2002) has gone furthest, with 26 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)—

What is it indicated for?

The VUEPORT is intended for use to access the coronary sinus and perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.

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

More from Cardima, Inc.

12 FDA decisions under this applicant name. See the company

  • K060715Modification to: Cardima Ablation SystemCardima, Inc. · 20062 recalls
  • K022008Cardima Ablation SystemCardima, Inc. · 20032 recalls
  • K974683Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
  • K972803Tracer O-T-W Mapping DeviceCardima, Inc. · 1999
  • K982835Electrode Switchbox, Model 11-081002Cardima, Inc. · 1998

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
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  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K973298 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973298: Cardima Vueport Coronary Sinus Balloon Occlusion Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973298

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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