Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD
FDA 510(k) K993816 · Baxter Edwards
510(k) numberK993816
Submission
- Device name
- Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- November 10, 1999
- Decision date
- May 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
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|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
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|---|---|---|
| K981909 | Baxter Hemostasis Valve IntroducersDYB · Traditional | 11/24/1998SE |
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| K965137 | Fogarty Valvulotome Model 700091MGZ · Traditional | 06/04/1997SE |
| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | 03/27/1997SE |
| K955839 | Multi-Med Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/25/1996SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
| K944858 | Baxter Eptfe Externally Supported Vascular GraftsDSY · Traditional | 01/05/1995ST |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | 05/24/1994SE |
| K926433 | 4.5F Imagecath(R) Coronary Angioscope, COV45LYK · Traditional | 03/23/1993SE |
Questions and answers
When was Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD cleared by the FDA?
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD (K993816) received a 510(k) decision of Substantially Equivalent on May 4, 2000, 176 days after the submission was received.
What is the product code of K993816?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.