Chrysalis Intelligence · Sponsors · Delta Med Spa

Delta Med Spa

Viadana, IT · 1 510(k) clearances · 11 recalls

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Total clearances
1
2020-08-26 → 2020-08-26
Last 12 months
0
Product codes
1
Most recent
2020-08-26
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II General Hospital 1 2020-08-26
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
11
Most recent
2021-06-21
DateSeverityStatusRecall # ProductCodeReason
2021-06-21 Class II Ongoing Z-2305-2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2304-2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2303-2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2302-2021 NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2301-2021 NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2300-2021 NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2299-2021 NEO DELTA Self Safe, I.V. Catheter REF 3738222 — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2298-2021 DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 38520… — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2297-2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d)… — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2296-2021 DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF … — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21 Class II Ongoing Z-2295-2021 DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272 — Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-08-26 K200373 Deltaven Fast Flash Closed I.V. Catheter Systems FOZ Class II General Hospital
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence