PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
FDA 510(k) clearance K030381 · decided 2003-08-27
Clearance details
- K-number
- K030381
- Device name
- PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
- Applicant
- Portex , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-05
- Decision date
- 2003-08-27
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- England Ct21 6db, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Portex
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
| Record | Firm | Date |
|---|---|---|
| Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 recall (Z-0714-06) | Smiths Medical ASD, Inc. | 2006-04-06 |