The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Cool Line Catheter, Model Cl-2295a, Icy Catheter, Model Ic-3893a And Quattro Catheter, Model Ic-4593.
| Device ID | K101987 |
| 510k Number | K101987 |
| Device Name: | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ZOLL CIRCULATION 650 ALMANOR AVENUE Sunnyvale, CA 94085 |
| Contact | Sam Nanavati |
| Correspondent | Sam Nanavati ZOLL CIRCULATION 650 ALMANOR AVENUE Sunnyvale, CA 94085 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2010-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849111075534 | K101987 | 000 |
| 00849111075121 | K101987 | 000 |
| 00849111075114 | K101987 | 000 |
| 00849111075107 | K101987 | 000 |
| 00849111075091 | K101987 | 000 |
| 00849111075084 | K101987 | 000 |
| 00849111075077 | K101987 | 000 |
| 00849111075060 | K101987 | 000 |
| 00849111075053 | K101987 | 000 |
| 00849111075046 | K101987 | 000 |
| 00849111075039 | K101987 | 000 |
| 00849111050074 | K101987 | 000 |
| 00849111050050 | K101987 | 000 |
| 00849111075138 | K101987 | 000 |
| 00849111075145 | K101987 | 000 |
| 00849111075176 | K101987 | 000 |
| 00849111075527 | K101987 | 000 |
| 00849111075510 | K101987 | 000 |
| 00849111075503 | K101987 | 000 |
| 00849111075282 | K101987 | 000 |
| 00849111075275 | K101987 | 000 |
| 00849111075268 | K101987 | 000 |
| 00849111075251 | K101987 | 000 |
| 00849111075237 | K101987 | 000 |
| 00849111075220 | K101987 | 000 |
| 00849111075213 | K101987 | 000 |
| 00849111075190 | K101987 | 000 |
| 00849111075183 | K101987 | 000 |
| 00849111050043 | K101987 | 000 |