510(k) · Cleared
Recalled · Class I · 2024POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRA Catheter, Steerable
Cleared on Mar 22, 2023 as substantially equivalent to K123591 (Medtronic Cryocath, LP, 2012) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 2007. 1 of the 11 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 22, 2023
- Review
- 91 days
- Class
- Class II
- Product code
- DRA
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K070357 (2007). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK070357 Flexcath Steerable Sheath & DilatorCryocath Technologies, Inc. · 2007
- 3 generations backK081049 Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc. · 2008
- 2 generations backK102176 Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10…Medtronic Cryocath, LP · 2010 · Recalled
- 1 generation backK123591 Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP · 2012
- This deviceK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023
- Descendant · cites it directly · 2 of its ownK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK262165 FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK250529 Globe Introducer (601-01001)Kardium, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · cites it directly2descendants
- K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026 · 2 generations on0descendants
- K250529Globe Introducer (601-01001)Kardium, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070357 | Flexcath Steerable Sheath & Dilator | Cryocath Technologies, Inc. | 2007 | — |
| −3 | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008 | — |
| −2 | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… | Medtronic Cryocath, LP | 2010 | 1 |
| −1 | K123591 | Flexcath Advance Steerable Sheath (12 French) | Medtronic Cryocath, LP | 2012 | — |
| 0 (this device) | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | — |
| +1 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| +2 | K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026 | — |
| +2 | K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K123591 | Flexcath Advance Steerable Sheath (12 French)Summary page 6…ressure Sensor Cable III. PREDICATE DEVICE INFORMATION Predicate Device #1: Flexcath Advance Steerable Sheath (12 French) Manufacturer: Medtronic Cryocath LP 510(k) #: K123591 FDA Clearance Date: 27 December 2012 Product Code: DRA Predicate Device for: POLARSHEATHTM Steerable Sheath 12F Predicate Device… | 2012 |
| * | K162892 | Achieve Advance Mapping CatheterSummary page 6…Product Code: DRA Predicate Device for: POLARSHEATHTM Steerable Sheath 12F Predicate Device #2: Achieve Advance Mapping Catheter Manufacturer: Medtronic Inc. 510(k) #: K162892 FDA Clearance Date: 15 November 2016 Product Code: DRF Predicate Device for: POLARMAPTM Circular Mapping Catheter, POLARMAPTM EP… | 2016 |
| † | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233248 | FARADRIVE™ Steerable Sheath | 2023 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2024 | Class I | Z-1302-2024 | Process control | Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K233248 (Boston Scientific Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K123591.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping…
Read the full statement (287 words)
The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional.
The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional.
The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional.
NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated.
The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.
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/K223824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223824: POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223824
Report an extraction error
Are you the manufacturer?
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