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FDA 510(k)

STRATOFUSE PCA INFUSER

K-Number: K905696 · 1991-03-08

ApplicantStrato Medical Corp.
Decision Date1991-03-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STRATOFUSE PCA INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1991-03-08 under 510(k) number K905696. 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 STRATOFUSE PCA INFUSER?

STRATOFUSE PCA INFUSER is a medical device that received FDA 510(k) clearance on 1991-03-08. The listed applicant is Strato Medical Corp.. The 510(k) number is K905696.

When did STRATOFUSE PCA INFUSER receive FDA 510(k) clearance?

STRATOFUSE PCA INFUSER received FDA 510(k) clearance on 1991-03-08, under 510(k) number K905696.

Who is the listed applicant for STRATOFUSE PCA INFUSER?

The FDA 510(k) record lists Strato Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATOFUSE PCA INFUSER?

The FDA product code for STRATOFUSE PCA INFUSER is FRN.

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Other records listing Strato Medical 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.

K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMSK946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMSK942848STRATO MEDICAL LIFEPORT LPS 7515K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEMK932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORTK933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM

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Related Devices (Code: FRN)

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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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