510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hangzhou Bever Medical Devices Co., Ltd.

Hangzhou Zhejiang, CN

Hangzhou Bever Medical Devices Co., Ltd. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Hangzhou Bever Medical Devices Co., Ltd. between 2012 and 2019. The busiest year on record is 2012, with 3. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hangzhou Bever Medical Devices Co., Ltd., by decision year
YearClearances
20123
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic CatheterGBMSubstantially Equivalent
K111406BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)BTRSubstantially Equivalent
K111401BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBEBTRSubstantially Equivalent
K111405BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,GBMSubstantially Equivalent

Registered establishments

FDA registered establishments for Hangzhou Bever Medical Devices Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087299103008729910Hangzhou Bever Medical Devices Co., Ltd.Building 2, No. 1-1, Houmuqiao, Hangzhou Zhejiang 311121 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1061-2026BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14FLabeling error, Incorrect expiration dateClass IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain