510(k) · Cleared
Recalled · 2010Itg Vascular Access System, Model 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arstasis, Inc. · DYB Introducer, Catheter
Cleared on Feb 25, 2010 as substantially equivalent to K041486 (Cardiva Medical, Inc., 2004) and 3 other predicates after a 323-day review. Its family tree reaches back 4 generations to 1995. 12 later devices descend from it. It has been recalled once.
- Decided
- Feb 25, 2010
- Review
- 323 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K945616 (1995). 12 ancestors in all, the oldest K915280 (1992). 12 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 3 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
- 2 generations backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- 1 generation backK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
- This deviceK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
- Descendant · 4 generations on · 8 of its ownK113110 Axera Access SystemArstasis, Inc. · 2011
- Descendant · 5 generations on · 7 of its ownK121521 Axera Access SystemArstasis, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100615Arstasis Access SystemArstasis, Inc. · 2010 · cites it directly11descendants
- K102728Arstasis Access SystemArstasis, Inc. · 2010 · 2 generations on10descendants
- K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 3 generations on9descendants
- K113110Axera Access SystemArstasis, Inc. · 2011 · 4 generations on8descendants
- K121521Axera Access SystemArstasis, Inc. · 2012 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| −3 | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | 2 |
| −2 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| −1 | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | 3 |
| 0 (this device) | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | — |
| +1 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +2 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +3 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
| +4 | K113110 | Axera Access System | Arstasis, Inc. | 2011 | — |
| +5 | K121521 | Axera Access System | Arstasis, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K041486 | Vasostasis Vascular Closure SystemSummary page 1…Names: Catheter, Introducer §870.1340 (DYB) Classification: Class II PREDICATE DEVICES Cardiva Medical, Inc. Vasostasis / Boomerang System (K04 1486 / K061075) Boston Scientific Super Sheath Introducer Sheath (K060190) Merit Medical Prelude Introducer Sheath!/ Kit (K071059) IN… | 2004 |
| * | K061075 | Boomerang WireSummary page 1…Catheter, Introducer §870.1340 (DYB) Classification: Class II PREDICATE DEVICES Cardiva Medical, Inc. Vasostasis / Boomerang System (K04 1486 / K061075) Boston Scientific Super Sheath Introducer Sheath (K060190) Merit Medical Prelude Introducer Sheath!/ Kit (K071059) INTENDED USE… | 2006 |
| * | K060190 | Super Sheath XL Introducer SheathSummary page 1…: Class II PREDICATE DEVICES Cardiva Medical, Inc. Vasostasis / Boomerang System (K04 1486 / K061075) Boston Scientific Super Sheath Introducer Sheath (K060190) Merit Medical Prelude Introducer Sheath!/ Kit (K071059) INTENDED USE/INDICATIONS FOR USE The Arstasis ITG Vascular Access Syste… | 2006 |
| * | K070159 | Prelude Sheath Introducer Our reading of the summary gave K071059, FDA’s number for Depuy Spa Porous Coated Proximal Sleeve (DePuy Orthopaedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Merit Medical Prelude Introducer Sheath/ Kit”. | 2007 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100615 | Arstasis Access System | 2010 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2010 | Not classified | Z-0993-2011 | Device Design | Device has the potential to fracture and sheath separation during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K100615 (Arstasis, Inc., 2010) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K041486.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ITG Vascular Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The ITG Vascular Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091006: Itg Vascular Access System, Model 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091006
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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