510(k) K913803
- Device
- INTRALUMINAL ARTERY STRIPPER
- Applicant
- OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
- 510(k) number
- K913803
- Product code
- DWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-24
- Date received
- 1991-08-26
- Regulation
- 870.4875
- Classification name
- Stripper, Artery, Intraluminal
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE STULL
- Address
- 403 County Rd., E2 W. St. Paul MN US 55112 55112
FDA Registration Numbers#
- 9611616
- 3010041511
- 1319639
- 3011137372
- 3011050570
- 3033536312
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121415 | MOLLRING MULTITASC | LeMaitre Vascular, Inc. | 2012-09-05 |
| K032105 | ENDOHELIX ENDARTERECTOMY DEVICE | Endarx, Inc. | 2003-10-30 |
| K020925 | CARBODISSECTING ENDOSCOPE | Endo Surgical Devices, Inc. | 2003-04-29 |
| K003719 | VASCULAR ARCHITECTS PERISCOPE DEVICE | Vascular Architects, Inc. | 2001-02-28 |
| K950813 | MOLLRING CUTTER | Cardio Vascular Concepts, Inc. | 1995-07-25 |
| K933498 | EXTERNAL VEIN STRIPPER | Applied Medical Resources | 1994-03-23 |
| K911099 | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Pilling Co. | 1991-06-25 |
| K904944 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Baxter Healthcare Corp | 1990-12-17 |
| K895878 | OLYMPUS VALVULOTOME W/DETACHABLE TIP | Olympus Corp. | 1990-01-02 |
| K894496 | OLYMPUS VALVULOTOME W/FIXED TIP | Olympus Corp. | 1989-10-12 |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1989-05-23 |
| K841521 | SCANLAN ENDARSECTOR | Scanlan Intl., Inc. | 1984-08-03 |
| K801063 | HALL ARTERIAL OSCILLATOR | American Sterilizer Co. | 1980-09-26 |
Legacy Summary#
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FDA Review#
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