The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Stimucath Continuous Nerve Block Set, Product Number Ab-05000.
Device ID | K021567 |
510k Number | K021567 |
Device Name: | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 |
Classification | Anesthesia Conduction Kit |
Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
Contact | William G Mclain |
Correspondent | William G Mclain ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-13 |
Decision Date | 2002-06-19 |
Summary: | summary |