510(k) · Cleared
ClearedGore Balloon Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Jun 29, 2007 as substantially equivalent to K001917 (Arteria Medical Science, Inc., 2001) and 2 other predicates after a 101-day review. Its family tree reaches back 1 generation to 2001. 2 of the 10 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Jun 29, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003085 (2001). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK003085 Concentric Guide Catheter, Models 90018, 90020Concentric Medical, Inc. · 2001
- This deviceK070770 Gore Balloon SheathW. L. Gore & Associates, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK123156 Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · cites it directly5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 2 generations on2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on0descendants
- K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003085 | Concentric Guide Catheter, Models 90018, 90020 | Concentric Medical, Inc. | 2001 | — |
| 0 (this device) | K070770 | Gore Balloon Sheath | W. L. Gore & Associates, Inc. | 2007 | — |
| +1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +3 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +4 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
| +2 | K123156 | Gore Flow Reversal System Model GFRS073 | W. L. Gore & Associates, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2023 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K001917 | Parodi Catheter for Angiography (Parca)Summary page 2…ds the requirements of the standard and performs substantially equivalent to the predicate devices. Predicate Devices: * ArteriA Medical ParCA Catheter K001917 * ArteriA Medical Occlusion Balloon K002286 * Concentric, Concentric Guide Catheter K003085 Summary of Substa… | 2001 |
| * | K002286 | Ldob Occlusion Balloon CatheterSummary page 2…antially equivalent to the predicate devices. Predicate Devices: * ArteriA Medical ParCA Catheter K001917 * ArteriA Medical Occlusion Balloon K002286 * Concentric, Concentric Guide Catheter K003085 Summary of Substantial Equivalence: The GORE Balloon Sheath and… | 2001 |
| * | K003085 | Concentric Guide Catheter, Models 90018, 90020Summary page 2…icate Devices: * ArteriA Medical ParCA Catheter K001917 * ArteriA Medical Occlusion Balloon K002286 * Concentric, Concentric Guide Catheter K003085 Summary of Substantial Equivalence: The GORE Balloon Sheath and Dilator are substantially equivalent to the predicate dev… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083300 | Gore Flow Reversal System | 2009 | 5 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070770: Gore Balloon Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070770
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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