510(k) K030813 ยท EZL Catheter, Retention Type, Balloon
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
| Applicant | Primary Care Solutions, Inc., Zephyrhills FL, US |
| Decision | Substantially Equivalent, May 30, 2003 |
| Received | Mar 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B Open, Classified |
NGT | None listed |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/5163 Open, Classified |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover KIT/STERILE PRESERVE CULT
Item Code: 8000SA
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
KOY | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREM U/M 14FR TMP SNS CSD
Item Code: P4P14TSD P400
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREM U/M 14FR SLVR FLY
Item Code: P4P14XSD P400
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 UM 16FR SIL COUDE SECURE
Item Code: P4P16CSDK
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 16FR SIL FLY
Item Code: P4P16SD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 16FR TMP SNS CSD
Item Code: P4P16TSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 16FR UL FOLY CSD
Item Code:P4P16ULD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 16FR SLVR FLY
Item Code: P4P16XSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM UM 16FR SILV TMP CSD
Item Code: P4P16XTSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE
Item Code: P4P18CSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 UM 18FR SIL COUDE SECURE
Item Code: P4P18CSDK
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 18FR SIL FLY
Item Code: P4P18SD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover P400 PREM U/M 18FR UL FOLY CSD
Item Code: P4P18ULD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover 400 PREM U/M 18FR SLVR FLY
Item Code: P4P18XSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PRECSION PRM 14FR SIL FLY
Item Code: PP14SD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREC PRM 14FR SILVER FLY TY
Item Code: PP14XSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE
Item Code: PP16CSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PRECSION PRM 16FR SIL FLY
Item Code: PP16SD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD
Item Code: PP16ULD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREC PRM 16FR SILVER FLY TY
Item Code: PP16XSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE
Item Code: PP18CSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PRECSION PRM 18FR SIL FLY
Item Code: PP18SD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD
Item Code: P18ULD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
| Mar 21, 2016 | Covidien LLC Covidien Dover PREC PRM 18FR SILVER FLY TY
Item Code: PP18XSD
Castile soap towelettes are used to clean the genital area for male and female patients Terminated |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.