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FDA 510(k)

CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.

K-Number: K854964 · 1986-03-07

ApplicantDeltec Systems, Inc.
Decision Date1986-03-07
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. is the device name listed in this FDA 510(k) record. The listed applicant is Deltec Systems, Inc.. It received FDA 510(k) clearance on 1986-03-07 under 510(k) number K854964. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.?

CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. is a medical device that received FDA 510(k) clearance on 1986-03-07. The listed applicant is Deltec Systems, Inc.. The 510(k) number is K854964.

When did CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. receive FDA 510(k) clearance?

CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. received FDA 510(k) clearance on 1986-03-07, under 510(k) number K854964.

Who is the listed applicant for CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.?

The FDA 510(k) record lists Deltec Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.?

The FDA product code for CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. is FRN.

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Other records listing Deltec Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERSK870768AC ADAPTER ACCESSORY, PRODUCT CODE 600123AK862927CADD-1, MODEL 5100 HFK853584CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMPK850183CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50MK843773CADD-PAC 5200 AMBULATORY INFUSION PUMP

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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