Lemaitre Retrograde Valvulotome-Manu-Surgica Instr
FDA 510(k) K850394 · Vascutech, Inc.
510(k) numberK850394
Submission
- Device name
- Lemaitre Retrograde Valvulotome-Manu-Surgica Instr
- Applicant
- Vascutech, Inc.
Washington, DC, US - Received
- February 1, 1985
- Decision date
- April 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001621 | Dardik Carotid ShuntMJN · Traditional | 12/06/2000SE |
| K992942 | Lemaitre Occlusion CatheterMJN · Traditional | 04/13/2000SE |
| K992933 | Lemaitre Irrigation CatheterDXE · Traditional | 03/08/2000SE |
| K992934 | Lemaitre Venous Thrombectomy CatheterDXE · Traditional | 03/01/2000SE |
| K992940 | Lemaitre Balloon Catheter with IrrigationDXE · Traditional | 02/22/2000SE |
| K992941 | Lemaitre Biliary CatheterLQR · Traditional | 01/12/2000SE |
| K992368 | Lemaitre Embolectomy CatheterDXE · Traditional | 12/09/1999SE |
| K980723 | 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)MGZ · Traditional | 02/12/1999SE |
| K946352 | Lemaitre Valvulotome IIMGZ · Traditional | 06/21/1995SE |
| K932009 | The Samuels Retrograd ValvulotomeMGZ · Traditional | 09/21/1993SE |
Questions and answers
When was Lemaitre Retrograde Valvulotome-Manu-Surgica Instr cleared by the FDA?
Lemaitre Retrograde Valvulotome-Manu-Surgica Instr (K850394) received a 510(k) decision of Substantially Equivalent on April 24, 1985, 82 days after the submission was received.
What is the product code of K850394?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.