510(k) · Cleared
Recalled · 2007CPS Direct SL Outer Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQY Catheter, Percutaneous
Cleared on Feb 24, 2006 as substantially equivalent to K021587 (Medtronic Vascular, 2002) and 3 other predicates after a 93-day review. Its family tree reaches back 6 generations to 1989. It has been recalled once.
- Decided
- Feb 24, 2006
- Review
- 93 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K893658 (1989). 48 ancestors in all, the oldest K760385 (1976). No later device cites it as a predicate yet.
- Root · 6 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 4 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 3 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 2 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 1 generation backK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- This deviceK053277 CPS Direct SL Outer CatheterSt Jude Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −5 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −4 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −2 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −1 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| 0 (this device) | K053277 | CPS Direct SL Outer Catheter | St Jude Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K021587 | Attain LDS 6216A Left-Heart Delivery System, Model 6216ASummary page 1…Percuatenous Classification: Class 11, 21 CFR 870.1250 Legally marketed device to which your firm is claiming equivalence: Medtronic AttainTM LDS (K021587) Attain Access (K021589), Guidant RapidoTM Cut-Away/Advance (K031505) Device Description: The out… | 2002 |
| * | K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218Summary page 1…ion: Class 11, 21 CFR 870.1250 Legally marketed device to which your firm is claiming equivalence: Medtronic AttainTM LDS (K021587) Attain Access (K021589), Guidant RapidoTM Cut-Away/Advance (K031505) Device Description: The outer catheter is an introd… | 2002 |
| * | K031505 | Rapido Cut-Away Guiding CatheterSummary page 1…ich your firm is claiming equivalence: Medtronic AttainTM LDS (K021587) Attain Access (K021589), Guidant RapidoTM Cut-Away/Advance (K031505) Device Description: The outer catheter is an introducer that is used to cannulate the Coronary Sinus (CS). The CPS Direct SL… | 2003 |
| * | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliverySummary page 2…ilar technology, have similar intended uses, functions, materials and methods of operation as the following predicate devices. · Medtronic AttainTM LDS/Access, K042194, K021589 * Guidant RapidoTM Cut-Away/Advance, K031505 Summary of Studies: Device comparison testing was performed to su… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2007 | Not classified | Z-0933-2007 | Other | Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 48 ancestors have a recall of any class.
- 4 other devices also cite its predicate K021587.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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 St. Jude Medical Slittable DirectTM Outer Guide Catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053277: CPS Direct SL Outer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053277
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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