3M Brand Microvascular Anastomotic Coupler (27XX)
FDA 510(k) K861985 · 3M Company
510(k) numberK861985
Submission
- Device name
- 3M Brand Microvascular Anastomotic Coupler (27XX)
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- May 22, 1986
- Decision date
- December 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MVR – Device, Anastomotic, Microvascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MVR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190499 | Gem FlowCoupler SystemMVR · Traditional | Baxter/ Synovis Micro Companies Alliance, Inc. | 09/06/2019SE |
| K191252 | Gem FlowCoupler SystemMVR · Traditional | Baxter/ Synovis Micro Companies Alliance, Inc. | 07/09/2019SE |
| K143589 | GEM Flow COUPLER Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 01/16/2015SE |
| K142309 | GEM Flow COUPLER Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 09/16/2014SE |
| K132727 | Gem Flow Coupler Device and SystemMVR · Special | Synovis Life Technologies, Inc. | 10/22/2013SE |
| K093310 | Gem Flow Coupler Device and SystemMVR · Traditional | Synovis Micro Companies Alliance, Inc. | 02/01/2010SE |
| K090679 | Vesselink Microvascular Anastomotic Coupler SystemMVR · Traditional | Vioptix, Inc. | 04/17/2009SE |
| K040163 | Microvascular Anastomotic DeviceMVR · Traditional | Synovis Micro Companies Alliance, Inc. | 04/16/2004SE |
More from Synovis Micro Companies Alliance, Inc.
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Brand Microvascular Anastomotic Coupler (27XX) cleared by the FDA?
3M Brand Microvascular Anastomotic Coupler (27XX) (K861985) received a 510(k) decision of Substantially Equivalent on December 4, 1986, 196 days after the submission was received.
What is the product code of K861985?
The FDA product code is MVR – Device, Anastomotic, Microvascular, a Class II (moderate risk) device regulated under 21 CFR 878.4300.