510(k) · Cleared
ClearedSelectra 3D Outer Guiding Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 16, 2020 as substantially equivalent to K192996 (Biotronik, Inc., 2019) after a 305-day review. Its family tree reaches back 6 generations to 2010. 2 later devices descend from it.
- Decided
- Oct 16, 2020
- Review
- 305 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K101776 (2010). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK101776 Scoutpro AcsBiotronik, Inc. · 2010
- 5 generations backK110461 Selectra CS Lead Introducer SystemBiotronik, Inc. · 2011
- 4 generations backK111154 Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra…Biotronik, Inc. · 2011
- 3 generations backK151409 Selectra Catheters and Selectra Accessory KitBiotronik, Inc. · 2015
- 2 generations backK183265 Selectra Catheters, Selectra Accessory KitBiotronik, Inc. · 2018
- 1 generation backK192996 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolBiotronik, Inc. · 2019
- This deviceK193474 Selectra 3D Outer Guiding CathetersBiotronik, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK222037 Selectra Lead Implantation SystemBiotronik, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK240787 Selectra 3D Lead Delivery System (443624-443629, 451789-451791)…Biotronik, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K101776 | Scoutpro Acs | Biotronik, Inc. | 2010 | — |
| −5 | K110461 | Selectra CS Lead Introducer System | Biotronik, Inc. | 2011 | — |
| −4 | K111154 | Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75 | Biotronik, Inc. | 2011 | — |
| −3 | K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015 | — |
| −2 | K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018 | — |
| −1 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2019 | — |
| 0 (this device) | K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | 2020 | — |
| +1 | K222037 | Selectra Lead Implantation System | Biotronik, Inc. | 2022 | — |
| +2 | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra… | Biotronik, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (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 | Decided |
|---|---|---|---|
| * | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolSummary page 4…ter (21 CFR 870.1250) Regulatory Class II Product Code DQY 3. Predicate Devices x BIOTRONIK’s Selectra 7F Guiding Outer Catheters, (K192996, cleared November 21, 2019) 4. Device Description BIOTRONIK's Selectra lead introducer system is a combination of guiding ca… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222037 | Selectra Lead Implantation System | 2022 | 1 |
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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 11 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K222037 (Biotronik, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192996.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193474 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193474: Selectra 3D Outer Guiding Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193474
Report an extraction error
Are you the manufacturer?
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