Medtronic Octopus Te Stabilizer & Accessories
FDA 510(k) K041338 · Medtronic Vascular
510(k) numberK041338
Submission
- Device name
- Medtronic Octopus Te Stabilizer & Accessories
- Applicant
- Medtronic Vascular
Brooklyn Park, MN, US - Received
- May 20, 2004
- Decision date
- July 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWS – Stabilizer, Heart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
Other 510(k)s with product code MWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992476 | Pilling Weck Surgical Heart Stabilizer Removable PadsMWS · Traditional | Pilling Weck Surgical | 09/13/2000SE |
| K992833 | Vacuum Assist StabilizerMWS · Traditional | Cardio Thoracic Systems | 11/10/1999SE |
| K982419 | Heart-Lift Balloon PositionerMWS · Traditional | Cardiothoracic Systems, Inc. | 01/13/1999SE |
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Questions and answers
When was Medtronic Octopus Te Stabilizer & Accessories cleared by the FDA?
Medtronic Octopus Te Stabilizer & Accessories (K041338) received a 510(k) decision of Substantially Equivalent on July 19, 2004, 60 days after the submission was received.
What is the product code of K041338?
The FDA product code is MWS – Stabilizer, Heart, a Class I (low risk) device regulated under 21 CFR 870.4500.