510(k) Report

510(k) · Cleared

Recalled · 2011

Rapido Cut-Away Guiding Catheter

K031505510(k) SpecialCleared Jun 25, 200342-day reviewClass II21 CFR 870.1250Recalls 1

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

Guidant Corporation · DQY Catheter, Percutaneous

Cleared on Jun 25, 2003 as substantially equivalent to K021455 (Guidant Corp., 2002) after a 42-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it. It has been recalled once.

Decided
Jun 25, 2003
Review
42 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K953987 (1995). 4 ancestors in all. 21 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2010: 2 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2025: 4 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK953987 · Acs Tourgide Guiding Catheter · Advanced Cardiovascular Systems, Inc. · 1995×2: 2 generations cleared close together, K021284 (2002), K021455 (2002) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K021455 · Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782, · Guidant Corp. · 2002 · recalledK021284 · Easytrak Guiding Catheter · Guidant Corp. · 2002 · recalledK953987 · Acs Tourgide Guiding Catheter · Advanced Cardiovascular Systems, Inc. · 19950+5
  1. Root · 3 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
  2. 2 generations backK021284 Easytrak Guiding CatheterGuidant Corp. · 2002 · Recalled
  3. 1 generation backK021455 Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F…Guidant Corp. · 2002 · Recalled
  4. This deviceK031505 Rapido Cut-Away Guiding CatheterGuidant Corporation · 2003
  5. Descendant · cites it directly · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
  6. Descendant · 2 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
  7. Descendant · 3 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
  8. Descendant · 4 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
  9. Descendant · 5 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12009: 12010: 22011: 22013: 12014: 12017: 12018: 12019: 12020: 12022: 12023: 12025: 42026: 1
2006high 4 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 21 · See all
  • K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · cites it directly14descendants
  • K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 2 generations on13descendants
  • K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 3 generations on12descendants
  • K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 4 generations on8descendants
  • K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953987Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc.1995—
−2K021284Easytrak Guiding CatheterGuidant Corp.200217
−1K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model#…Guidant Corp.200218
0 (this device)K031505Rapido Cut-Away Guiding CatheterGuidant Corporation2003—
+1K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland2006—
+2K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide…Medtronic, Inc.2008—
+3K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left…Medtronic, Inc.2009—
+4K101885Medtronic C315 Delivery CatheterMedtronic, Inc.20101
+5K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3…Centerpoint Systems2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
200910
201020
201120
201310
201410
201710
201810
201910
202010
202210
202310
202540
202610
FIG. 1 — Lineage of K031505, 1995–2026Source: 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), 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
*K021455Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…Guidant Corp.200218

Also cleared against K021455: 3 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614
K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc.20104
K053277CPS Direct SL Outer CatheterSt Jude Medical20060

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 7, 2011Not classifiedZ-2793-2011Process controlFive lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K053431 (Medtronic, Ireland, 2006) has gone furthest, with 14 descendants of its own.
  • 3 other devices also cite its predicate K021455.

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 Guidant RAPIDO Cut-Away Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Indications for use as stated in the FDA summary.

Also cleared against K021455

3 other devices cite the same predicate.

  • K101015Guide Catheters and AccessoriesThomas Medical Products, Inc. · 2010
  • K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148St Jude Medical · 20065 recalls
  • K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004

More from Guidant Corporation

15 FDA decisions under this applicant name. See the company

  • K060449HI-Torque Advance and Advance Lite Guide WireGuidant Corporation · 2006
  • K053459Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006
  • K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
  • K053019Acuity Steerable Stylet AccessoryGuidant Corporation · 2006
  • K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K031505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031505: Rapido Cut-Away Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031505

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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