EXTRACORPOREAL BLOOD CIRCUIT
FDA 510(k) clearance K982340 · decided 1999-04-30
Clearance details
- K-number
- K982340
- Device name
- EXTRACORPOREAL BLOOD CIRCUIT
- Applicant
- Haidylena Medical Egypt
- Decision
- Substantially Equivalent
- Date received
- 1998-07-06
- Decision date
- 1999-04-30
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Nasr City, Cairo, EG
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Haidylena Medical Egypt
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.