Mehigan-Pilling Phlebetome TM
FDA 510(k) K911100 · Pilling Co.
510(k) numberK911100
Submission
- Device name
- Mehigan-Pilling Phlebetome TM
- Applicant
- Pilling Co.
Fort Washington, PA, US - Received
- March 12, 1991
- Decision date
- June 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| K260188 | LimFlow VectorMGZ · Special | LimFlow, Inc. | 03/18/2026SE |
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| K221902 | LimFlow VectorMGZ · Traditional | LimFlow, Inc. | 12/21/2022SE |
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| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 04/10/2014SE |
| K132047 | Lemills ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 11/05/2013SE |
| K132190 | Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 08/05/2013SE |
| K111884 | Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 07/29/2011SE |
| K080178 | Valvulotome by KovenMGZ · Traditional | Koven Technology, Inc. | 07/28/2008SE |
More from Koven Technology, Inc.
| 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 |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | 06/25/1991SE |
| 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 Phlebetome TM cleared by the FDA?
Mehigan-Pilling Phlebetome TM (K911100) received a 510(k) decision of Substantially Equivalent on June 21, 1991, 101 days after the submission was received.
What is the product code of K911100?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.