510(k) · Cleared
ClearedArrow Transseptal Super Arrow-Flex Percutaneous Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DYB Introducer, Catheter
Cleared on Feb 13, 1998 after a 388-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.
- Decided
- Feb 13, 1998
- Review
- 388 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 6 citing it directly.
- This deviceK970229 Arrow Transseptal Super Arrow-Flex Percutaneous SetArrow Intl., Inc. · 1998
- Descendant · cites it directly · 13 of its ownK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
- Descendant · cites it directly · 8 of its ownK083793 Steerable Guide CatheterEvalve, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008 · cites it directly13descendants
- K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005 · cites it directly9descendants
- K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · 2 generations on8descendants
- K083793Steerable Guide CatheterEvalve, Inc. · 2009 · cites it directly8descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970229 | Arrow Transseptal Super Arrow-Flex Percutaneous Set | Arrow Intl., Inc. | 1998 | — |
| +1 | K081341 | Reinforced Catheter Introducer System (Rcis) | Thomas Medical Products, Inc. | 2008 | — |
| +1 | K043084 | Premere Delivery Sheath, Model PDS | Velocimed, Inc. | 2005 | — |
| +2 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 30 |
| +1 | K083793 | Steerable Guide Catheter | Evalve, Inc. | 2009 | — |
| +3 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | — | Arrow Super Arrow-Flex® percutaneous sheath introducer sets Named without a submission number | |
| * | — | Bard Mullins transseptal catheter introducer set Named without a submission number | |
| * | — | Daig Fast-Cath™ transseptal introducer Named without a submission number |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081341 | Reinforced Catheter Introducer System (Rcis) | 2008 | 13 |
| K043084 | Premere Delivery Sheath, Model PDS | 2005 | 9 |
| K083793 | Steerable Guide Catheter | 2009 | 8 |
| K122958 | Delivery Sheath, Model Adelante Breezeway | 2012 | 2 |
| K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath | 2004 | 1 |
| K171988 | Performer Guiding Sheath | 2018 | 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?
- Of its descendants, K081341 (Thomas Medical Products, Inc., 2008) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer set, is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various cardiovascular devices into the left side of the heart through the interatrial septum.
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/K970229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970229
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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