SecurePortIV Advanced Catheter Securement Adhesive
FDA 510(k) clearance K223669 · decided 2023-06-12
Clearance details
- K-number
- K223669
- Device name
- SecurePortIV Advanced Catheter Securement Adhesive
- Applicant
- Adhezion Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-12-07
- Decision date
- 2023-06-12
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- NZP
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hudson, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Adhezion Biomedical
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.
| Record | Firm | Date |
|---|---|---|
| SecurePortIV Catheter Securement Adhesive (K170505) | Adhezion Biomedical, LLC | 2017-09-29 |
| FLORASEAL, MODEL FS350D (K083354) | Adhezion Biomedical | 2009-07-20 |
| INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (K052870) | Kimberly-Clark Corp. | 2006-09-29 |
Recalls involving this device
No recalls on record reference this clearance.