510(k) · Cleared
ClearedExtension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Instruments · KGZ Accessories, Catheter
Cleared on Nov 2, 1976 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Nov 2, 1976
- Review
- 89 days
- Class
- Class I
- Product code
- KGZ
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 1 citing it directly.
- This deviceK760385 Extension SetsB. Braun Instruments · 1976
- Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- Descendant · 2 generations on · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
- Descendant · 3 generations on · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
- Descendant · 4 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
- Descendant · 5 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
- K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · 2 generations on17descendants
- K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · 3 generations on14descendants
- K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 4 generations on13descendants
- K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K760385 | Extension Sets | B. Braun Instruments | 1976 | — |
| +1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| +2 | K042194 | Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery | Medtronic Vascular | 2004 | — |
| +3 | K053431 | Attain Select II 6248DEL Delivery Catheter System | Medtronic, Ireland | 2006 | — |
| +4 | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide… | Medtronic, Inc. | 2008 | — |
| +5 | K090659 | Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left… | Medtronic, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | 2003 | 29 |
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?
- Of its descendants, K031211 (Medtronic Vascular, 2003) has gone furthest, with 29 descendants of its own.
How does its category compare?
All KGZ devicesKGZ Accessories, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGZ
FDA has decided no KGZ device since 2007.
Median 510(k) review, days · KGZ
Too few KGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KGZ
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGZ
30in 2025
MAUDE reports naming product code KGZ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 4 | 7 |
| 2010 | 0 | — | 2 | 37 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 78 |
| 2018 | 0 | — | 0 | 100 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 0 | — | 1 | 113 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 88 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 3 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K760385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K760385: Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760385
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026