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 Boston Scientific Corporation, St Jude Medical and Medtronic Cryocath, LP.

42
Total
42
Cleared
102d
Avg days
1984
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 64d recently vs 104d historically

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

42 devices
1–24 of 42
Cleared Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
K262165
Boston Scientific Corporation
Cardiovascular · 28d
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
Cleared Jan 19, 2006
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575
St Jude Medical
Cardiovascular · 122d
Cleared May 12, 2004
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165
St Jude Medical
Cardiovascular · 107d
Cleared Jan 26, 1993
RESPONSE(TM) STEERABLE CATHETER
K913940
Daig Corp.
Cardiovascular · 511d
Cleared Jan 27, 1984
ADULT VENT CATHETER
K834352
Dlp, Inc.
Cardiovascular · 45d

About Product Code DRA - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code DRA since 1984, with 42 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - DRA Product Code

Recent submissions under DRA have taken an average of 64 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.

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