510(k) · Cleared
Recalled · Class II · 2012Z Flex-270TM Steerable Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Batch Medical · DRA Catheter, Steerable
Cleared on Feb 7, 2012 as substantially equivalent to K102176 (Medtronic Cryocath, LP, 2010) after a 159-day review. Its family tree reaches back 3 generations to 2007. It has been recalled once.
- Decided
- Feb 7, 2012
- Review
- 159 days
- Class
- Class II
- Product code
- DRA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070357 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 2 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 1 generation backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- This deviceK112541 Z Flex-270TM Steerable SheathGreat Batch Medical · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −2 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −1 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| 0 (this device) | K112541 | Z Flex-270TM Steerable Sheath | Great Batch Medical | 2012 | — |
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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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 |
|---|---|---|---|
| * | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…Summary page 1…21 CFR 870.1280 Classification Panel: Cardiovascular 3.0 Predicate Device The subject device is equivalent to the following device: *K102 176 - Medtronic FlexCath Steerable Sheath and Dilator 4.0 Description of Device The Z'Flex-270TM Steerable Sh… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2012 | Class II | Z-2459-2012 | Nonconforming Material/Component | During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K102176.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Z'Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112541: Z Flex-270TM Steerable Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112541
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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