Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
FDA 510(k) clearance K202176 · decided 2020-09-03
Clearance details
- K-number
- K202176
- Device name
- Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
- Applicant
- Medical Components, Inc. (dba MedComp)
- Decision
- Substantially Equivalent
- Date received
- 2020-08-04
- Decision date
- 2020-09-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Components
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.