Imager Flush Catheters
FDA 510(k) K884354 · Medi-Tech, Inc.
510(k) numberK884354
Submission
- Device name
- Imager Flush Catheters
- Applicant
- Medi-Tech, Inc.
Watertown, MA, US - Received
- October 17, 1988
- Decision date
- April 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
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| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was Imager Flush Catheters cleared by the FDA?
Imager Flush Catheters (K884354) received a 510(k) decision of Substantially Equivalent on April 21, 1989, 186 days after the submission was received.
What is the product code of K884354?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.