510(k) K211100
- Device
- AcQGuide MAX Steerable Sheath
- Applicant
- Acutus Medical, Inc.
- 510(k) number
- K211100
- Product code
- DRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-14
- Date received
- 2021-04-13
- Regulation
- 870.1280
- Classification name
- Catheter, Steerable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Serena Sanginthirath
- Address
- 2210 Faraday Ave., Suite 100 Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 1123137
- 1721676
- 2017865
- 3005334138
- 3027305778
- 2184009
- 3002648230
- 1047843
- 3007113487
- 2011171
- 3002807314
- 9681260
- 1928237
- 9617601
- 3012179728
- 1225698
- 3015309643
- 3006950086
- 3007014520
- 2024311
- 2182269
- 3004859241
- 2135147
- 3015970743
- 3009420598
- 3012536737
- 3013288201
- 3007603855
- 1000121056
- 2939561
- 3005941719
- 3033589330
- 3005070406
- 9612164
- 3015225571
- 3010665433
- 3020950818
- 3003955307
- 1721504
- 2124215
- 2953359
- 2183744
- 3019807891
- 2182208
- 9611665
- 1056553
Source Documents#
Other 510(k) Records For Product Code DRA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025-06-03 |
| K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023-12-11 |
| K232321 | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | 2023-10-31 |
| 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 | Boston Scientific Corporation | 2023-03-22 |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | 2022-09-28 |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022-05-05 |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2020-11-13 |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | 2019-10-04 |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | 2019-05-29 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018-11-26 |
| K172394 | Steerable Guide Catheter | Abbott Vascular | 2017-09-06 |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017-04-06 |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016-09-20 |
| K161985 | Steerable Guide Catheter | Abbott Vascular | 2016-08-07 |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016-02-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases