FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MitraClip G4 Steerable Guide Catheter
K Number: K190167
·
Decision May 29, 2019
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
40
Applicant Total
12
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MitraClip G4 Steerable Guide Catheter
- K Number
- K190167
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1280
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott
- Date Received
- January 31, 2019
- Decision Date
- May 29, 2019
- Product Code
- DRA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRA | Catheter, Steerable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRA), ordered by most recent decision date.
Globe Introducer (601-01001)
FDA 510(k)
FDA Class 2
·Cardiovascular
FARADRIVE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
FlexCath Contour Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
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
FDA 510(k)
FDA Class 2
·Cardiovascular
MitraClip G4 Steerable Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AcQGuide® VUE Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Abbott
| K Number | Device Name | ||
|---|---|---|---|
| K260993 | Amplatzer TorqVue Delivery System | Apr 24, 2026 | Substantially Equivalent |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Sep 17, 2025 | Substantially Equivalent |
| K233655 | Lingo Glucose System | May 29, 2024 | Substantially Equivalent |
| K222297 | CentriMag Pre-connected Pack | Dec 1, 2022 | Substantially Equivalent |
| K221213 | EnSite X EP System | Aug 18, 2022 | Substantially Equivalent |
| K212061 | EnSite X EP System | Oct 22, 2021 | Substantially Equivalent |
| K210392 | WorkMate Claris System | Mar 11, 2021 | Substantially Equivalent |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Oct 18, 2019 | Substantially Equivalent |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Mar 29, 2019 | Substantially Equivalent |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Dec 12, 2018 | Substantially Equivalent |