Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311
FDA 510(k) K021974 · Minimed, Inc.
510(k) numberK021974
Submission
- Device name
- Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311
- Applicant
- Minimed, Inc.
Northridge, CA, US - Received
- June 17, 2002
- Decision date
- August 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K191910 | SpaceStation MRIMRZ · Traditional | B. Braun Melsugen AG | 03/12/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | Welldoc, Inc. | 11/04/2019SE |
| K173531 | Lockbox for Perfusor Space PCA Infusion PumpMRZ · Traditional | B.Braun Medical, Inc. | 08/02/2018SE |
| K171346 | Sapphire SetsMRZ · Traditional | Icu Medical | 08/25/2017SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | Welldoc, Inc. | 01/12/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | Hospira, Inc. | 12/06/2016SE |
More from Hospira, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K031541 | Paradigmpal, Model MMT-7330LZG · Traditional | 11/18/2003SE |
| K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712LGZ · Traditional | 07/23/2003SE |
| K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterLZG · Traditional | 06/17/2003SE |
| K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385KZH · Traditional | 04/05/2001SE |
| K001832 | Paradigm Sof-Set Ultimate QR, Models 317 and 318FPA · Traditional | 08/18/2000SE |
| K001829 | Minimed Paradigm Insulin Pump, Model 511FRN · Traditional | 08/18/2000SE |
| K001828 | Paradigm 1.5ML Reservoir, Model 326FRN · Traditional | 08/18/2000SE |
| K001827 | Paradigm Sof-Set Micro QR, Models 324 and 325FPA · Traditional | 08/18/2000SE |
Questions and answers
When was Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311 cleared by the FDA?
Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311 (K021974) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 50 days after the submission was received.
What is the product code of K021974?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.