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FDA 510(k)

DRAINAGE BAG, IMPROVED, FLAT

K-Number: K770490 · 1977-03-21

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1977-03-21
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE BAG, IMPROVED, FLAT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1977-03-21 under 510(k) number K770490. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAINAGE BAG, IMPROVED, FLAT?

DRAINAGE BAG, IMPROVED, FLAT is a medical device that received FDA 510(k) clearance on 1977-03-21. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K770490.

When did DRAINAGE BAG, IMPROVED, FLAT receive FDA 510(k) clearance?

DRAINAGE BAG, IMPROVED, FLAT received FDA 510(k) clearance on 1977-03-21, under 510(k) number K770490.

Who is the listed applicant for DRAINAGE BAG, IMPROVED, FLAT?

The FDA 510(k) record lists Pharmaseal Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAINAGE BAG, IMPROVED, FLAT?

The FDA product code for DRAINAGE BAG, IMPROVED, FLAT is KNX.

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Other records listing Pharmaseal Div., Baxter Healthcare Corp. 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.

K792369HYPERALIMENTATION DRESSING TRAYK792141CONTINUOUS FLUSH DEVICEK792019PHADECODE XA INHIBITOR ASSAYK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTER

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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