MitraClip G4 Steerable Guide Catheter
FDA 510(k) K221397 · Abbott Medical
510(k) numberK221397
Submission
- Device name
- MitraClip G4 Steerable Guide Catheter
- Applicant
- Abbott Medical
St.Paul, MN, US - Received
- May 13, 2022
- Decision date
- September 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott | 05/29/2019SE |
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Questions and answers
When was MitraClip G4 Steerable Guide Catheter cleared by the FDA?
MitraClip G4 Steerable Guide Catheter (K221397) received a 510(k) decision of Substantially Equivalent on September 28, 2022, 138 days after the submission was received.
What is the product code of K221397?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.