510(k) · Cleared

Recalled · 2011

Rapido Cut-Away Cutter

K031459510(k) TraditionalCleared Jul 23, 200376-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 Corp. · DQY Catheter, Percutaneous

Cleared on Jul 23, 2003 as substantially equivalent to K024035 (Medtronic Vascular, 2002) after a 76-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it. It has been recalled once.

Decided: Jul 23, 2003
Review: 76 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K024035 (2002). 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK024035 Attain 6218A-AM Amplatz Guide Catheter for Left-Heart DeliveryMedtronic Vascular · 2002
This deviceK031459 Rapido Cut-Away CutterGuidant Corp. · 2003
Descendant · cites it directly · 3 of its ownK111252 Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp · 2011
Descendant · 2 generations on · 2 of its ownK132914 Acuity Pro Lead Delivery SystemBoston Scientific · 2014 · Recalled
Descendant · 3 generations on · 1 of its ownK171612 ACUITY Pro Lead Delivery SystemBoston Scientific Corporation · 2017
Descendant · 4 generations on · 0 of its ownK243757 Shockwave CS Guide CatheterShockwave Medical, Inc. · 2025
Descendant · cites it directly · 0 of its ownK080154 Acuity Universal CutterCardiac Pacemakers, Inc. · 2008 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp · 2011 · cites it directly3descendants
K132914Acuity Pro Lead Delivery SystemBoston Scientific · 2014 · 2 generations on2descendants
K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation · 2017 · 3 generations on1descendant
K243757Shockwave CS Guide CatheterShockwave Medical, Inc. · 2025 · 4 generations on0descendants
K080154Acuity Universal CutterCardiac Pacemakers, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K024035	Attain 6218A-AM Amplatz Guide Catheter for Left-Heart Delivery	Medtronic Vascular	2002	—
0 (this device)	K031459	Rapido Cut-Away Cutter	Guidant Corp.	2003	—
+1	K111252	Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F	Boston Scientific Corp	2011	—
+2	K132914	Acuity Pro Lead Delivery System	Boston Scientific	2014	1
+3	K171612	ACUITY Pro Lead Delivery System	Boston Scientific Corporation	2017	—
+4	K243757	Shockwave CS Guide Catheter	Shockwave Medical, Inc.	2025	—
+1	K080154	Acuity Universal Cutter	Cardiac Pacemakers, Inc.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2014	1	0
2017	1	0
2025	1	0

FIG. 1 — Lineage of K031459, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K024035	Attain 6218A-AM Amplatz Guide Catheter for Left-Heart Delivery Summary page 1 …valent to the predicate device. 7. Conclusion The Guidant RAPIDO Cut-Away Cutters are substantially equivalent to the currently marketed Medtronic Attain Cutters (K024035, cleared 12/30/02) with regards to intended use and design. 5 IO(k) Submission for Guidant RAPIDO Guiding Catheter…	Medtronic Vascular	2002	—

Also cleared against K024035: 2 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K111252	Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F	Boston Scientific Corp	2011	3
K080154	Acuity Universal Cutter	Cardiac Pacemakers, Inc.	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 7, 2011	Not classified	Z-2793-2011	Process control	Five 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?

Its one ancestor has no recall.
Of its descendants, K111252 (Boston Scientific Corp, 2011) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K024035.

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

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut-Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031459: Rapido Cut-Away Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031459

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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