Percutaneous Atrial Catheter Kit (OFK) contract manufacturers
5 US facilities list FDA product code OFK as a contract manufacturer (0) or contract sterilizer (5).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Percutaneous Atrial Catheter Kit
- Product code
- OFK (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Classification panel
- Cardiovascular
Where they are
Texas 3 · Massachusetts 1 · North Carolina 1
All 5 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Northborough, MA | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; General hospital +13 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
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