510(k) · Cleared
ClearedMedtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F Launcher Biopsy Catheter, Model LA8RVBB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQY Catheter, Percutaneous
Cleared on Jul 31, 2003 as substantially equivalent to K022764 (Medtronic Vascular, 2002) and 2 other predicates after a 150-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Jul 31, 2003
- Review
- 150 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K981198 (1998). 6 ancestors in all, the oldest K944668 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 3 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 2 generations backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
- This deviceK030671 Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB…Medtronic Vascular · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −3 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −2 | K022764 | 7F Launcher Guide Catheter | Medtronic Vascular | 2002 | 13 |
| −1 | K023402 | 8F Launcher Guide Catheter | Medtronic Vascular | 2002 | 18 |
| 0 (this device) | K030671 | Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F… | Medtronic Vascular | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K022764 | 7F Launcher Guide CatheterSummary page 2…equate for the intended use. The guide catheters are considered to be substantially equivalent to the following device: 0 7F Launcher Guide Catheter (K022764) 0 8F Launcher Guide Catheter (K023402) 0 SHERPA, SHERPA I1 (commercialized as Vector) and ASCENT… | 2002 |
| * | K023402 | 8F Launcher Guide CatheterSummary page 2…considered to be substantially equivalent to the following device: 0 7F Launcher Guide Catheter (K022764) 0 8F Launcher Guide Catheter (K023402) 0 SHERPA, SHERPA I1 (commercialized as Vector) and ASCENT biopsy Guide Catheters (K944668) === Pa… | 2002 |
| * | K944668 | Sherpa Sherpa II and Ascent Coronary Guiding CathetersSummary page 2…764) 0 8F Launcher Guide Catheter (K023402) 0 SHERPA, SHERPA I1 (commercialized as Vector) and ASCENT biopsy Guide Catheters (K944668) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 5 of the 6 ancestors have a recall of any class.
- 6 other devices also cite its predicate K022764.
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 Medtronic 7F and 8F Launcher Right Ventricular Biopsy Guiding Catheters are intended to be used for the percutaneous introduction of biopsy forceps into thle right ventricle of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030671: Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F Launcher Biopsy Catheter, Model LA8RVBB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030671
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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