primeMidline Catheters
FDA 510(k) clearance K192802 · decided 2019-10-28
Clearance details
- K-number
- K192802
- Device name
- primeMidline Catheters
- Applicant
- Pfm Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2019-10-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- PND
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pfm Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NIT-OCCLUD PDA (P120009/S004) | Pfm Medical, Inc. | 2024-10-17 |
| PMA NIT-OCCLUD PDA (P120009/S003) | Pfm Medical, Inc. | 2016-12-16 |
| NIT-OCCLUD SYSTEM (P120009/S002) | Pfm Medical, Inc. | 2015-01-21 |
| NIT-OCCLUD PDA (P120009/S001) | Pfm Medical, Inc. | 2014-08-01 |
| NIT-OCCLUD PDA (P120009) | Pfm Medical, Inc. | 2013-08-16 |