PERIPHERAL ATHERECTOMY SYSTEM
FDA 510(k) clearance K890515 · decided 1989-05-23
Clearance details
- K-number
- K890515
- Device name
- PERIPHERAL ATHERECTOMY SYSTEM
- Applicant
- Intensive Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-01
- Decision date
- 1989-05-23
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- DWX
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MOLLRING MULTITASC (K121415) | LeMaitre Vascular, Inc. | 2012-09-05 |
| ENDOHELIX ENDARTERECTOMY DEVICE (K032105) | Endarx, Inc. | 2003-10-30 |
| CARBODISSECTING ENDOSCOPE (K020925) | Endo Surgical Devices, Inc. | 2003-04-29 |
| VASCULAR ARCHITECTS PERISCOPE DEVICE (K003719) | Vascular Architects, Inc. | 2001-02-28 |
| MOLLRING CUTTER (K950813) | Cardio Vascular Concepts, Inc. | 1995-07-25 |
| EXTERNAL VEIN STRIPPER (K933498) | Applied Medical Resources | 1994-03-23 |
| INTRALUMINAL ARTERY STRIPPER (K913803) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1992-04-24 |
| MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (K911099) | Pilling Co. | 1991-06-25 |
| TRANSLUMINAL ENDARTERECTOMY DEVICE (K904944) | Baxter Healthcare Corp | 1990-12-17 |
| OLYMPUS VALVULOTOME W/DETACHABLE TIP (K895878) | Olympus Corp. | 1990-01-02 |
| OLYMPUS VALVULOTOME W/FIXED TIP (K894496) | Olympus Corp. | 1989-10-12 |
| SCANLAN ENDARSECTOR (K841521) | Scanlan Intl., Inc. | 1984-08-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S004) | Intensive Technology, Inc. | 1998-12-30 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S005) | Intensive Technology, Inc. | 1998-02-23 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S003) | Intensive Technology, Inc. | 1998-01-29 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S002) | Intensive Technology, Inc. | 1996-09-17 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S001) | Intensive Technology, Inc. | 1995-01-05 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019) | Intensive Technology, Inc. | 1993-05-18 |