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FDA 510(k)

ENTERAL PUMP SET W/ENTERA-FLO SPIKE

K-Number: K895650 · 1990-10-02

ApplicantDelmed, Inc.
Decision Date1990-10-02
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERAL PUMP SET W/ENTERA-FLO SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1990-10-02 under 510(k) number K895650. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERAL PUMP SET W/ENTERA-FLO SPIKE?

ENTERAL PUMP SET W/ENTERA-FLO SPIKE is a medical device that received FDA 510(k) clearance on 1990-10-02. The listed applicant is Delmed, Inc.. The 510(k) number is K895650.

When did ENTERAL PUMP SET W/ENTERA-FLO SPIKE receive FDA 510(k) clearance?

ENTERAL PUMP SET W/ENTERA-FLO SPIKE received FDA 510(k) clearance on 1990-10-02, under 510(k) number K895650.

Who is the listed applicant for ENTERAL PUMP SET W/ENTERA-FLO SPIKE?

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

What is the FDA product code for ENTERAL PUMP SET W/ENTERA-FLO SPIKE?

The FDA product code for ENTERAL PUMP SET W/ENTERA-FLO SPIKE is KNT.

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Other records listing Delmed, 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.

K895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONK900106CLOSED DISCONNECT SYSTEM

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Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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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