Mehigan-Pilling Angioscopic Vascular Instrum. Line
FDA 510(k) K911099 · Pilling Co.
510(k) numberK911099
Submission
- Device name
- Mehigan-Pilling Angioscopic Vascular Instrum. Line
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- March 12, 1991
- Decision date
- June 25, 1991
- 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
Other 510(k)s with product code DWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121415 | Mollring MultitascDWX · Traditional | LeMaitre Vascular, Inc. | 09/05/2012SE |
| K032105 | Endohelix Endarterectomy DeviceDWX · Traditional | Endarx, Inc. | 10/30/2003SE |
| 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 |
| K904944 | Transluminal Endarterectomy DeviceDWX · Traditional | Baxter Healthcare Corp | 12/17/1990SE |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | Olympus Corp. | 01/02/1990SE |
| K894496 | Olympus Valvulotome W/Fixed TipDWX · Traditional | Olympus Corp. | 10/12/1989SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K002582 | Pilling E-Frazier Bipolar Suction TubeGEI · Traditional | 11/03/2000SE |
| K934427 | Pilling Laparoscopic InstrumentationGEI · Traditional | 01/10/1994SE |
| K925370 | Triangular Jaw Microlaryngeal ForcepsELW · Traditional | 03/18/1993SE |
| K925198 | Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional | 02/12/1993SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | 09/23/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | 11/21/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | 06/21/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | 03/01/1991SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | 02/06/1989SE |
| K882930 | Laser Laryngoscope Dedo Articula. & Feder Dedo ExCCW · Traditional | 08/16/1988SE |
Questions and answers
When was Mehigan-Pilling Angioscopic Vascular Instrum. Line cleared by the FDA?
Mehigan-Pilling Angioscopic Vascular Instrum. Line (K911099) received a 510(k) decision of Substantially Equivalent on June 25, 1991, 105 days after the submission was received.
What is the product code of K911099?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.