DRA · Class II · 21 CFR 870.1280

FDA Product Code DRA: Catheter, Steerable

FDA product code DRA covers steerable catheters used in cardiac electrophysiology and structural heart procedures.

These catheters incorporate a deflectable tip controlled by a handle mechanism, allowing the operator to navigate complex cardiac anatomy and position the catheter precisely at target sites within the heart. They are used for electrophysiology mapping, ablation, and transeptal procedures.

DRA devices are Class II medical devices, regulated under 21 CFR 870.1280 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Cryocath, LP, Acutus Medical, Inc. and Boston Scientific Corporation.

41
Total
41
Cleared
104d
Avg days
1984
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 99d avg (recent)

FDA 510(k) Cleared Catheter, Steerable Devices (Product Code DRA)

41 devices
1–24 of 41
Cleared Jun 03, 2025
Globe Introducer (601-01001)
K250529
Kardium, Inc.
Cardiovascular · 99d
Cleared Dec 11, 2023
FARADRIVE™ Steerable Sheath
K233248
Boston Scientific Corporation
Cardiovascular · 74d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321
Medtronic, Inc.
Cardiovascular · 89d
Cleared Mar 22, 2023
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
K223824
Boston Scientific Corporation
Cardiovascular · 91d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397
Abbott Medical
Cardiovascular · 138d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044
Acutus Medical, Inc.
Cardiovascular · 27d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620
Medtronic Cryocath, LP
Cardiovascular · 64d
Cleared Oct 04, 2019
Steerable Introducer 12F
K192422
Freudenberg Medical, LLC
Cardiovascular · 30d
Cleared May 29, 2019
MitraClip G4 Steerable Guide Catheter
K190167
Abbott
Cardiovascular · 118d
Cleared Nov 26, 2018
FlexCath Advance Steerable Sheath and Dilator
K183174
Medtronic Cryocath, LP
Cardiovascular · 10d

About Product Code DRA - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code DRA since 1984, with 41 receiving FDA clearance (average review time: 104 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - DRA Product Code

FDA review times for DRA submissions have been consistent, averaging 99 days recently vs 104 days historically.

DRA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →