Scanlan Endarsector
FDA 510(k) K841521 · Scanlan Intl., Inc.
510(k) numberK841521
Submission
- Device name
- Scanlan Endarsector
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- April 12, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWX – Stripper, Artery, Intraluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
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|---|---|---|---|
| K121415 | Mollring MultitascDWX · Traditional | LeMaitre Vascular, Inc. | 09/05/2012SE |
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| K020925 | Carbodissecting EndoscopeDWX · Traditional | Endo Surgical Devices, Inc. | 04/29/2003SE |
| K003719 | Vascular Architects Periscope DeviceDWX · Traditional | Vascular Architects, Inc. | 02/28/2001SE |
| K950813 | Mollring CutterDWX · Traditional | Cardio Vascular Concepts, Inc. | 07/25/1995SE |
| K933498 | External Vein StripperDWX · Traditional | Applied Medical Resources | 03/23/1994SE |
| K913803 | Intraluminal Artery StripperDWX · Traditional | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 04/24/1992SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | Pilling Co. | 06/25/1991SE |
| K904944 | Transluminal Endarterectomy DeviceDWX · Traditional | Baxter Healthcare Corp | 12/17/1990SE |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | Olympus Corp. | 01/02/1990SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip SystemHCH · Traditional | 04/26/1996SE |
| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864920 | Scanlan (TM) Instrument TrayFSM · Traditional | 01/12/1987SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | 01/12/1987SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan Endarsector cleared by the FDA?
Scanlan Endarsector (K841521) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 113 days after the submission was received.
What is the product code of K841521?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.