510(k) · Cleared
ClearedStrada Carotid Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DYB Introducer, Catheter
Cleared on Apr 6, 2007 as substantially equivalent to K052185 (Terumo Medical Corp., 2005) after a 78-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Apr 6, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924607 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 2 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 1 generation backK052185 Destination Carotid Guiding SheathTerumo Medical Corp. · 2005 · Recalled
- This deviceK070166 Strada Carotid Guiding SheathSt Jude Medical · 2007
- Descendant · cites it directly · 0 of its ownK093130 Engage TR IntroducerSt Jude Medical · 2009 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K093130Engage TR IntroducerSt Jude Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −2 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −1 | K052185 | Destination Carotid Guiding Sheath | Terumo Medical Corp. | 2005 | 1 |
| 0 (this device) | K070166 | Strada Carotid Guiding Sheath | St Jude Medical | 2007 | — |
| +1 | K093130 | Engage TR Introducer | St Jude Medical | 2009 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K052185 | Destination Carotid Guiding SheathSummary page 1…PREDICATE DEVICE INFORMATION The predicate device is the Destination® Carotid Guiding Sheath manufactured by Terumo and cleared by premarket notification in 2005 (K052185). 4. DEVICE DESCRIPTION The StradaTM Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath.… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093130 | Engage TR Introducer | 2009 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K093130 (St Jude Medical, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052185.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The StradaTM Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to the carotid artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070166: Strada Carotid Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070166
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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