PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
FDA 510(k) clearance K113584 · decided 2012-03-02
Clearance details
- K-number
- K113584
- Device name
- PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
- Applicant
- St Jude Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-12-05
- Decision date
- 2012-03-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Westford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch St Jude Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
| OptoMonitor 3 (K241418) | Opsens, Inc. | 2025-02-12 |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) | Acist Medical Systems, Inc. | 2024-07-17 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| OptoMonitor 3 (K202943) | Opsens, Inc. | 2020-11-24 |
| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TactiSys Quartz Equipment; Ampere Generator (P130026/S102) | St Jude Medical | 2026-08-07 |
| Ampere Generator (P960016/S094) | St Jude Medical | 2026-08-07 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S100) | St Jude Medical | 2026-06-05 |
| TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S101) | St Jude Medical | 2026-05-29 |
| TactiCath CF Ablation Catheter, Sensor Enabled (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- (P130026/S099) | St Jude Medical | 2026-05-15 |
| TactiCath Sensor Enabled (P130026/S098) | St Jude Medical | 2026-01-15 |
| Livewire TC XLS (P960016/S093) | St Jude Medical | 2026-01-15 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S097) | St Jude Medical | 2026-01-08 |