Millennium Valve Introducer/Rotator Handle
FDA 510(k) K980016 · Genzyme Surgical Product (Genzyme Biosurgery)
510(k) numberK980016
Submission
- Device name
- Millennium Valve Introducer/Rotator Handle
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
North Attleboro, MA, US - Received
- January 2, 1998
- Decision date
- August 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOP – Rotator, Prosthetic Heart Valve
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Specialty
- Cardiovascular
Other 510(k)s with product code MOP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974648 | Sulzer Carbomedics Low Profile Mitral RotatorMOP · Traditional | Sulzer Carbomedics, Inc. | 08/04/1998SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 04/29/1996SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 06/20/1995SE |
More from Carbomedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001440 | Nextstitch Cardiovascular Valve SutureGAT · Traditional | 11/13/2000SE |
| K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureGAT · Traditional | 06/12/2000SN |
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 09/03/1999SE |
| K991416 | Endoscopic CameraGCJ · Traditional | 07/20/1999SE |
| K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 06/22/1999SE |
| K990062 | SaphliftMDM · Traditional | 03/30/1999SE |
| K982712 | Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250CAC · Traditional | 12/18/1998SE |
| K981322 | Cutalon Nylon Polyamide Surgical SutureGAR · Traditional | 07/07/1998SE |
Questions and answers
When was Millennium Valve Introducer/Rotator Handle cleared by the FDA?
Millennium Valve Introducer/Rotator Handle (K980016) received a 510(k) decision of Substantially Equivalent on August 7, 1998, 217 days after the submission was received.
What is the product code of K980016?
The FDA product code is MOP – Rotator, Prosthetic Heart Valve, a Class I (low risk) device regulated under 21 CFR 870.3935.