510(k) · Cleared
Recalled · Class II · 2021Cordis Avanti+Catheter Sheath Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Apr 24, 1997 as substantially equivalent to K954595 (Cordis Corp., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1995. 25 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 24, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945616 (1995). 2 ancestors in all. 25 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- This deviceK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997
- Descendant · cites it directly · 24 of its ownK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 22 of its ownK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · cites it directly24descendants
- K070159Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · 2 generations on22descendants
- K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · 3 generations on12descendants
- K100615Arstasis Access SystemArstasis, Inc. · 2010 · 4 generations on11descendants
- K102728Arstasis Access SystemArstasis, Inc. · 2010 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| 0 (this device) | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | — |
| +1 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| +2 | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | 3 |
| +3 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| +4 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +5 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 DRE? 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K954595 | Cordis Brite Tip Sheath IntroducerSummary page 1…cer or Sheath Introducer System Proprietary Name: Cordis Avanti + Catheter Sheath Introducer System Name of Predicate Devices Brite Tip Catheter Sheath Introducer, K 9954595, October 02, 1995 Avanti™ Catheter Sheath Introducer, K 945616, November 14, 1994 Classification Class Il Performance Standards… | 1995 |
| * | K945616 | Cordis Avanti Catheter Sheath IntroducerSummary page 1…nti + Catheter Sheath Introducer System Name of Predicate Devices Brite Tip Catheter Sheath Introducer, K 9954595, October 02, 1995 Avanti™ Catheter Sheath Introducer, K 945616, November 14, 1994 Classification Class Il Performance Standards Performance standards have not been established by the FDA un… | 1995 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050962 | Merit Prelude Sheath Introducer | 2005 | 24 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2021 | Class II | Z-2079-2021 | Under Investigation by firm | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. |
| Dec 31, 2015 | Class II | Z-1174-2016 | Mixed-up of materials/components | Incorrect cannula of the sheath introducer (smaller than intended). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970392 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970392: Cordis Avanti+Catheter Sheath Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970392
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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