Atlas FDA

ANESTHESIA KIT, EPIDURAL, SINGLE SHOT

FDA 510(k) clearance K770356 · decided 1977-03-01

Clearance details

K-number
K770356
Device name
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1977-02-22
Decision date
1977-03-01
Days to decision
7 days
Clearance type
Traditional
Product code
CAZ
Device class
2
Regulation number
868.5140
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Arrow Intl.

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.

RecordFirmDate
Arrow 0.2 Micron Flat Filter, GVS (K222341)Arrow International, LLC2023-02-13
BD Epilor Syringe (K210983)Becton, Dickinson and Company2022-05-19
Plastic LOR Syringe (K201356)Jiangsu Caina Medical Co.,Ltd2021-02-12
E-Cath STIM acc. Tsui (K202699)PAJUNK GmbH Medizintechnologie2020-12-29
VPC (K190345)PAJUNK GmbH Medizintechnologie2019-05-16
Arrow Epidural Catheter Kit (K161075)Teleflexmedical, Inc.2016-10-04
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652)Teleflex, Inc.2016-06-21
Arrow Epidural Catheter Kit (K143581)Teleflexmedical, Inc.2015-06-26
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (K122690)Arrow International, Inc.2012-12-21
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (K110053)Smiths Medical Asd, Inc.2012-09-14
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (K122027)Arrow International, Inc.2012-08-28
PERIFUSE CATHETER (K121525)Smiths Medical Asd, Inc.2012-08-02

Recalls involving this device

RecordFirmDate
SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH recall (Z-1343-2011)Arrow International Inc2011-02-17
EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) EPIDURAL CATHETER -- Product SKU (Code) recall (Z-1350-2011)Arrow International Inc2011-02-17
ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-0400 recall (Z-1351-2011)Arrow International Inc2011-02-17
EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Ep recall (Z-1352-2011)Arrow International Inc2011-02-17
PREP TRAY/Product SKU (Code) ASK-04001-SLE. Prep tray for epidural anesthesia kit recall (Z-1353-2011)Arrow International Inc2011-02-17
NERVE BLOCK PREP TRAY/Product SKU (Code) ASK-04001-VCU. Nerve block prep tray for epidural recall (Z-1354-2011)Arrow International Inc2011-02-17
EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code) NH-05501. An recall (Z-1361-2011)Arrow International Inc2011-02-17